MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-02-03 for DEROYAL 1044-31 manufactured by Deroyal Industries, Inc..
[37442813]
Introduction during the time period of january 1, 2015 to january 29, 2016, deroyal has receive a total of 6 complaints reporting the malfunction of the emt select extrication collar at the blue molded piece. The reference for these are (b)(4). These were recently all reviewed again. As a result, deroyal has made the decision to file two additional mdrs due to breakage of this piece upon application of collar on a patient (for (b)(4)). Both of the mdrs are for events that deroyal became aware of 6 to 5 months ago. The reason for these mdrs being filed after the 30 day deadline per 21 cfr 803. 50, is that at the time these complaints were received, deroyal did not consider them to qualify as mdr reportable events per 21 cfr 803. 1 and 803. 3. Once we reviewed the reported events again and took into account what we have learned over the course of our investigation, it was decided to file reports for these. Mdrs were already filed for complaints (b)(4). Follow up reports will be submitted for these to update with most recent findings. This mdr is for complaint number (b)(4). The full list of mdr filed and corresponding complaint number are as follow: complaint (b)(4) - mdr 3006851902-2016-00005, complaint (b)(4) - mdr 3006851902-2016-00006, complaint (b)(4) - mdr 3006851902-2015-00001 (corresponding medwatch (b)(4)), complaint (b)(4) - mdr 3006851902-2015-00002 (corresponding medwatch (b)(4)), complaint (b)(4) - mdr 3006851902-2015-00003 (corresponding medwatch (b)(4)). Background the product 1044-31, cervical collar emt select, is also sold under six other part numbers: a111-000, 1044-30, 1044-90, 14-103a-00, 1117pp, and 300n10. This product used to be purchased from an outside vendor. In 2013, deroyal started manufacturing this product in-house. There was a previous investigation into complaints that reported breaks at the white polypropylene chin piece. The failure mode and corrective action for those occurrences are completely different than the malfunction described here (b)(4). Investigation findings in october of 2015, deroyal noticed four complaints (b)(4) that reported the emt select extraction collars breaking at the blue plastic piece (figure 1 in attachments). This piece is molded and made from high density polyethylene (hdpe) resin. It is called the adult front body, part number hdp0302b. As a result, a capa investigation was immediately initiated (b)(4). The manufacturing process was reviewed to verify compliance with deroyal procedures. No inconsistencies were found. Members of the investigation team attempted to reproduce the reported breaks. When handled as directed, investigators were unable to induce a break at the blue plastic piece. Of course a break can be induced if collar is handled roughly enough. Investigators notice that when collar is bent hard enough, the way this part breaks is the same for all collars tested and complaint samples. It starts at the v intersections where 2 ribs come together in the area at the neck of the blue front piece (see figure 2 in attachments). It was theorized that reinforcing this area for the collar may result in increased robustness to account for when the collar is not handled as intended. The area where the breaks occur was strengthened by adding a radius to the rib junctions. Reinforcing this area for the collar did result in increased robustness as was shown by our testing (attachment 1 and 2 - eng pcl 039 protocol and summary report). Figure 3 in the attachments shows a picture of this part with a description of the changes made to the corresponding molding tool. These changes were made on december 14, 2016. The first lot of our emt select extrication collars that incorporate this change has just been manufactured (lot 41545015 on 01/27/2016). As the new lots of our modified emt select extrication collars go out into the market, deroyal will continue to monitor trends for these failure types and will recognize if it becomes a recurring issue. Health risk assessment as part of our investigation, a health risk assessment (hra) was performed, in november 2015, to see if a product recall was necessary (attachment 3). The team that took part in the analysis had representatives from the following departments: regulatory, quality assurance, engineering r & d, marketing and manufacturing (engineering, molding and tooling). (1) investigators concluded that user error is the likely root cause. The user not handling the collar as intended. When applied as directed, investigators were unable to induce malfunction. However, malfunction could eventually be induced if the collar was bent or rolled tightly enough. This type of handling is not consistent with the instructions. (2) in the analysis, it was determined that if a device were to malfunction, it is unlikely to result in injury. If an injury were to occur it would most likely be either (a) temporary or reversible (without medical intervention) or (b) limited (transient, minor impairment or complaints). Consistent with this conclusion is that none of the complaints have reported a patient injury. (3) the estimated rate of unit reported per units sold was calculated to be 0. 021%. This was calculated by dividing the total number of units reported to break by the total number of units sold. Taking into account the recent information, this estimate is still valid. Between, january 1, 2015 and january 29, 2016, there have been a total of 32 collars reported to be malfunctioning and 160, 329 units sold. This results in an estimated rate of 0. 019% of malfunctioning units reported per unit sold. Based on the health risk assessment performed for this product, that the malfunctioning rate has not changed, that this product is ordered by and sold to customers quickly, and that the new modified product has started to be shipped out to customers, it is our opinion that no action is required at this time with respect to removing this product from commercial use or distribution. Root cause investigators concluded that user error is the likely root cause. The user not handling the collar as intended. When applied as directed, investigators were unable to induce malfunction. However, malfunction could eventually be induced if the collar was bent or rolled tightly enough. This type of handling is not consistent with the instructions. Corrective action the area where the breaks occur was strengthened by adding a radius to the rib junctions. Reinforcing this area for the collar did result in increased robustness as was shown by our testing (attachment 1 and 2 - eng pcl 039 protocol and summary report). Figure 3 in the attachments shows a picture of this part with a description of the changes made to the corresponding molding tool. These changes were made on december 14, 2016. The first lot of our emt select extrication collars that incorporate this change has just been manufactured (lot 41545015 on 01/27/2016). As the new lots of our modified emt select extrication collars go out into the market, deroyal will continue to monitor trends for these failure types and will recognize if it becomes a recurring issue. Preventive action a preventive action is not needed at this time. As the new lots of our modified emt select extrication collars go out into the market, deroyal will continue to monitor trends for these failure types and will recognize if it becomes a recurring issue. No further information is available at this time. We will provide follow up report if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[37442814]
Copied below are the questions and corresponding responses given by the initial reporter to the deroyal complaint questionnaire. Quality issue details: date of occurrence: (b)(6) 2015. When did quality issue occur? During use. Who was using or operating the product when the quality issue occurred? Health professional. Was a medical procedure involved? No name of medical procedure: not applicable. Did the quality issue cause a delay in the medical procedure? Not applicable. Detailed description of quality issue: e-mail from customer: "i am attaching a picture i took of our c collars that are busting. I was told by a medic that over the weekend when it was low 40's at night they had a car accident and went to use a collar and it busted. I scanned out a collar myself and bent it to place it on a medic and it was ok at room temp. I then placed a c collar in the refrigerator with a temp of 42 degrees and the collar did not break. I placed the collar in the freezer with a temp of 3 degrees and placed it on the medic and as you see in the picture it shattered. This will not work for ems as these are stored in the ambulances and we are outside most of the day with freezing temps (unfortunately) are rapidly approaching. I am sending this to see what our options are. " how was the quality issue was identified? By actual use. How was the product being used? On their ems unit... On a patient... Item cracked. Was it the initial use of the product? Yes. Was the product modified from the original condition supplied by deroyal? No. Was the product connected to or used in conjunction with other devices or equipment? No. Outcome details: outcome(s) attributed to quality issue: none. Person(s) affected by outcome(s) checked above: patient. Known pre-existing condition(s) of person(s) affected: n/a. Was the incident reported to the fda? No. Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: it seems that it is just this particular lot number. Medline distribution was informed (via the medline distribution rep) to sideline the remaining product of this lot number until deroyal reaches out with next steps.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006851902-2016-00005 |
| MDR Report Key | 5408595 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-03 |
| Date of Report | 2016-02-03 |
| Date of Event | 2015-10-14 |
| Date Facility Aware | 2015-10-14 |
| Date Mfgr Received | 2015-10-14 |
| Date Added to Maude | 2016-02-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. MARIAN VARGAS |
| Manufacturer Street | 200 DEBUSK LN |
| Manufacturer City | POWELL 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621013 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | KM7 AUTOPISTA JOAQUIN BALAGUER PISANO FREE ZONE, BUILDING 18 |
| Manufacturer City | SANTIAGO, DOMINICAN REPUBLIC |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | EMT SELECT EXTRICATION COLLAR |
| Product Code | IQK |
| Date Received | 2016-02-03 |
| Model Number | 1044-31 |
| Lot Number | 39676534 |
| Operator | EMERGENCY MEDICAL TECHNICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-03 |