MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRAPE,FEMORAL ANGIOGRAPHY,2 WND,ST,20/CS

Catalog Number	DYNJP4104
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the drap gets saturated, the surgeon is noticing that the fibers from the drape are coming off to the surgeons gloves and even the dye from the drape is coming to the gloves.
Additional Manufacturer Narrative
The customer reported that when the drape gets saturated, ¿the fibers from the drape are coming off to the surgeons gloves¿ and ¿the dye from the drape is coming to the gloves.¿ a sample and photo was returned by the customer; the customer was contacted and requested to provide additional information, the photos were reviewed, the sample was reviewed, the contract manufacturer was sent the investigation form to perform an investigation, and a trend review was performed.The photos show material from the reinforcement stuck to the customers gloves and missing from the drape; the returned drape was unused and found to meet product specifications, the drape was saturated, and medline was unable to duplicate the reported issue.The vendor states a probable cause may be poor material but was unable to duplicate the reported issue with samples at their facility; based on the results of the investigation medline was unable to determine the root cause, the review of trending did not indicate a trend of fibers coming off or similar occurring in the field, and no further actions are being taken at this time.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,FEMORAL ANGIOGRAPHY,2 WND,ST,20/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50766438
• Report Number: 1417592-2026-40266
• Device Sequence Number: 9550818
• Product Code: PUI
• UDI-Device Identifier: 10080196825479
• UDI-Public: 10080196825479
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/14/2026

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: DYNJP4104
• Device Lot Number: 11024040066
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2025
• 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: 03/13/2025
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown