MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRAPE,HIP,W/POUCH,ST,5/CS

Catalog Number	DYNJP8201
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have had 3 hip drapes over the last week or so that the pocket part where they drop the leg down into has ripped and contaminates the leg.".
Additional Manufacturer Narrative
According to the facility, the "hip drape has torn during a total hip procedure which required the facility to re-wrap the leg," and the complaint stated that the pocket part "has ripped and contaminates the leg." no sample was available for the investigation; medline reviewed the complaint history and nonconformance trending for this product and this customer for the past six months, and there were two additional complaints opened for this customer and item at the same time as this one.The issue is not confirmed, and the cause code states "sample required to determine cause." per the facility, no injury or medical intervention was required related to the reported incident, and medline will reopen the complaint if the sample becomes available.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: DRAPE,HIP,W/POUCH,ST,5/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50672598
• Report Number: 1417592-2026-33983
• Device Sequence Number: 15995989
• Product Code: PUI
• UDI-Device Identifier: 40080196740766
• UDI-Public: 40080196740766
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 09/03/2026

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: DYNJP8201
• Device Lot Number: 30523020004
• 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: 05/24/2023
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown