|
The account reported finding betadine leaked, and the original report stated that the incident did not occur during patient use.A photo and a sample were received; the sample was one unopened pack, and upon opening the pack a brown stain was observed on the back table cover, the prep tray that the pvp solution sits in was all stained by the pvp solution, no defects were observed with the bottle nor the cap, and the bottle was half way empty.The reported problem was confirmed, and production records and finished good pack build were reviewed with no non-conformances or issues noted that would have contributed to the reported issue.The cause was documented as supplier error and component/part defective, broke; the kitting division made the decision to discontinue the applicare pvp with a white cap and transition kits containing this item to an alternate item, and the complaint was provided to the component manufacturing facility for further evaluation.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
|
