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..
[37526338]
Introduction: during the time period of january 1, 2015 to january 29, 2016, deroyal has received a total of (b)(4) complaints reporting the emt select extrication collars breaking at the white chin piece. (b)(4). These were recently all reviewed again. As a result, deroyal has made the decision to file four mdrs due to breakage of this piece upon application of collar on a patient. Three of the mdrs are for events that deroyal became aware of 10 to 8 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. 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 3006851902-2016-00001 (there is a corresponding medwatch report for this mdr. The number is mw5058809. ); complaint (b)(4) - mdr 3006851902-2016-00002; complaint (b)(4) - mdr 3006851902-2016-00003; complaint (b)(4) - mdr 3006851902-2016-00004. 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. Investigation findings: in may of 2015, deroyal noticed six complaints (32797, 33149, 33182, 33193, 33194, 33248) that reported the emt select extraction collars breaking at the plastic piece under the chin (picture 1 - red ellipse marks the spot). This piece is molded and made from polypropylene resin. It is called the adult front body, part number ppf0302c. As a result, a capa investigation was immediately initiated ((b)(4)). First, members of the investigation team attempted to reproduce the reported breaks. However, when handled as directed, investigators were unable to induce a break at the white chin bridge. Then, the manufacturing process was reviewed to verify compliance with deroyal procedures. No inconsistencies were found during this review. Finally, experiments were run to find the root cause of the reported breaks. If a plastic piece were to break easily, it would be due to brittleness. A brittle plastic piece could lead to a break at the chin bridge. Two potential causes of brittleness are color load and molding temperature. It is possible that too high a color load could result in brittleness of the polypropylene (pp) materials in question. It is also possible that if the cooling rate of mold is too fast, then this could possibly result in brittleness. There are manufacturing specification ranges for both of these parameters. In an attempt to induce the malfunction, the team investigated the effect of variation two key molding parameters (molding temperature and color loading) on the corresponding plastic piece. Pp white molded pieces were molded at different color loads and molding temperature that represented the best case, worse case and midpoint scenarios. The resulting molded parts were manually and mechanically tested. No statistically significant difference found by either test for any of the molding conditions tested. After being unable to reproduce the reported failure by either experiment or manual handling of the collars, it was concluded that user error is the likely root cause. The end user applying the collars were not handling the product 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. One of our engineering investigators proposed that changing the pp resin used in molded part may lead to increase strength of the molded part. This in turn may make up for when the collar is not handled as intended. Test results (attachment 2 and 3 -- eng. Pcl. 001 protocol and summary report) show that molded parts using the proposed resin (10-6114) resulted in increased strength. An engineering change order (b)(4) (eco) was submitted and approved to change the polypropylene (pp) resin raw material. The first lot of this product that incorporated molded pieces with this new polypropylene resin was manufactured on 01/27/2016 (lot 41545015). 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 1). 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 (b)(4). 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. (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: one of our engineering investigators proposed that changing the pp resin used in molded part may lead to increase strength of the molded part. This in turn may make up for when the collar is not handled as intended. Test results (attachment 2 and 3 -- eng. Pcl. 001 protocol and summary report) show that molded parts using the proposed resin (10-6114) resulted in increased strength. An engineering change order 41800 (eco) was submitted and approved to change the polypropylene (pp) resin raw material. The first lot of this product that incorporated molded pieces with this new polypropylene resin was manufactured on 01/27/2016 (lot 41545015). 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
[37526343]
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: as the product was being placed on the patient, the plastic piece under the chin broke in half. It happened to 5 products in total. How was the quality issue was identified? By actual use. How was the product being used? On patients. 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: other. Person(s) affected by outcome(s) checked above: patient; facility employee. 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: both patient and health care professional were affected because new product needed to be located that didn't break (5 broke in total on this day).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006851902-2016-00004 |
| MDR Report Key | 5410485 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-04 |
| Date of Report | 2016-02-02 |
| Date of Event | 2015-05-02 |
| Date Facility Aware | 2015-05-02 |
| Date Mfgr Received | 2015-05-14 |
| 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 |
| Model Number | 1044-31 |
| 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 | 2016-02-04 |