MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-02-04 for DEROYAL 1044-31 manufactured by Deroyal Industries, Inc..
[37539932]
Introduction (b)(4) mdr 3006851902-2015-00001 (b)(4). Investigation findings (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. 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. 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. 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). 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. 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 temporary or reversible (without medical intervention) or limited (transient, minor impairment or complaints). Consistent with this conclusion is that none of the complaints have reported a patient injury. (b)(4). 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. Figure 3 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
[37539933]
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? Before 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: continued issues with the deroyal extrication collars. Originally reported on (b)(4). Per customer, the breaking/cracking of collars continued to occur. How was the quality issue was identified? By actual use. How was the product being used? Product was being place on a patient. 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: none. 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: customer stated that the collars were breaking on the first qfi submitted. Then customer reported an additional lot number of product that were also breaking. Outcome is that customer no longer wants to purchase the deroyal collar stating that in the emergency environment, they can't have products that they don't feel are consistent in regards to durability.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006851902-2016-00006 |
| MDR Report Key | 5409728 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-04 |
| Date of Report | 2016-02-03 |
| Date of Event | 2015-11-10 |
| Date Facility Aware | 2015-11-10 |
| Date Mfgr Received | 2015-11-30 |
| Date Added to Maude | 2016-02-04 |
| 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 | 2016-02-04 |
| Returned To Mfg | 2015-12-08 |
| Model Number | 1044-31 |
| Lot Number | 38063349 |
| Operator | EMERGENCY MEDICAL TECHNICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-02-04 |