A complaint was received on 02/03/2023 reporting sponges from pack have the threads coming out of sponges, note after incision, sponges removed from field.A supplier corrective action request (scar) was issued to the sponge supplier meixin medical.The actual sample was not available to be returned to deroyal for evaluation.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
|
A user facility medwatch report (#4900240000-2023-8019) was received reporting sponges from pack have the threads coming out of sponges, noted after incision, sponges removed from sterile field.A supplier corrective action request (scar) was issued to the sponge supplier meixin medical.A picture of the sample was provided to deroyal for evaluation.The picture showed an issue with gauze instead of a sponge that was initially reported.The following root cause was determined by the supplier meixin medical: the picture shows that the blue xr filament is falling out from the gauze in whole.There is no debris of yarn attached to the xr filament, which indicates that the xr filament is not adhering to the gauze solidly enough.The xr filament will be heated, softened, and then pressed on to the gauze.Key factors that will affect the solidity of the adhering are the temperature and the pressure.The manufacture record of the complaint lot was reviewed, and it was found that the heating system of the folding machine malfunctioned once during production.Employees failed to remove the nonconforming products.There was no inventory or work in process on hand to evaluate.The following corrective and preventive actions have been taken by meixin medical: the folding machine shall be checked and maintained regularly as required.The folding machine shall be stopped and repaired immediately if any abnormalities or malfunctions occur.The products produced before and after the malfunction shall be isolated and inspected retroactively to avoid nonconforming products.The employees were retrained on how to properly identify nonconforming products.Production records were reviewed, and no issues were found.An inventory check of the gauze was made by deroyal, a total of 2000 of the 5-19928 gauze was inspected, and no discrepancies were identified during the inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
|