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	10/14/2025
Type of Reportable Event	Other
Event or Problem Description
It was reported that the drape was "very difficult to open and drape over the patient" and "very \"sticky\" to open up and not easily drapeable.".
Additional Manufacturer Narrative
The customer reported that the drape was difficult to open due to the material sticking together; there was no reported death or serious injury.The customer was contacted and requested to provide additional information, the sample was reviewed, the contract manufacturer performed an investigation at their facility, and analysis of complaint data was performed.The sample was opened except one portion; the drape was not sticky on the opened part, the non-open part was sticking together, and the complaint issue was confirmed.The product did meet product specifications, no abnormalities or defects were found in the contract manufacturer's records, manufacturing process, and retained samples, no trend was identified, and medline was unable to determine the cause of the issue with the returned sample.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: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50872308
• Report Number: 1417592-2026-49277
• Device Sequence Number: 18820417
• Product Code: PUI
• UDI-Device Identifier: 10080196825479
• UDI-Public: 10080196825479
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Catalogue Number: DYNJP4104
• Device Lot Number: 61425080037
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/29/2025
• 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: 10/14/2025
• Initial Report FDA Received Date: 09/23/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown