MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PROT.,STA.,PLUS,W/DRAPE,CLIP,PG

Catalog Number	000000000064000945
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we seem to be having an issue with many of the protection stations breaking or coming in broken from a specific lot #.Inr has had 4 manifold break while setting up the table and 1 came in broken in the package.".
Additional Manufacturer Narrative
The customer reported "many of the protection stations breaking or coming in broken" and that "inr has had 4 manifold break while setting up the table and 1 came in broken in the package." photos were received for review from the customer, a stock check was performed for all available batches, the finished good bill of materials/pack build, manufacturing instructions, drawing, device history records, and receiving inspection records were reviewed.Based on review of the photos, the reported defect was confirmed as the protection station being broken/damaged, and based on the investigation results, the reported event was confirmed as the protection station being damaged/broken at the bond site.Root cause remains inconclusive at this time; no further action is required at this time, and medline will continue to monitor for additional occurrences and adverse trends.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.

• Brand Name: MEDLINE
• Common Device Name: PROT.,STA.,PLUS,W/DRAPE,CLIP,PG
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947174
• Report Number: 1417592-2026-54408
• Device Sequence Number: 9552470
• Product Code: FPA
• UDI-Device Identifier: 20193489059028
• UDI-Public: 20193489059028
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K2140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 000000000064000945
• Device Lot Number: 0000132757
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown