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

Catalog Number	DYNJP4104
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the barrier/film side of the drape is significantly stickier than normal production.When draping in the sterile field, it prevents sterile practice when unfolding the drape and has caused some instances of compromising sterility, having to break down and reset the field.
Additional Manufacturer Narrative
The customer reported that the barrier/film side of the drape is significantly stickier than normal production and that, when draping in the sterile field, it prevents sterile practice when unfolding the drape and has caused some instances of compromising sterility, having to break down and reset the field.The customer was contacted and requested to provide additional information; the photos were reviewed and showed the outside label and the drape; the sample was reviewed and met specifications but was difficult to open and sticking together; and the contract manufacturer reviewed records, manufacturing process, and retained samples and found no abnormalities or defects in their production.Based on the results of the investigation, the complaint issue was confirmed, but the root cause could not be determined.There was no reported death or serious injury associated with this event, no objectionable trend was identified, and no further investigation into the cause and complaint was warranted.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: michael mazeska ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50691147
• Report Number: 1417592-2026-34668
• Device Sequence Number: 9614704
• Product Code: PUI
• UDI-Device Identifier: 10080196825479
• UDI-Public: 10080196825479
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/04/2026

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: 61425090040
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/12/2026
• 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: 02/05/2026
• Initial Report FDA Received Date: 09/09/2026
• 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