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	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "with one motion the first 1/2 of the drape is opened, with some adherence of the plastic drape" and "the adherence causes the previously opened portion to shift/move and change the location of the sterile field".It was reported that "this renders the sterile drape technically unsterile as the portion of the drape that falls below the sterile plane has shifted up due to the adherence".
Additional Manufacturer Narrative
The customer reported that the drape was opened according to standard practice, with some adherence of the plastic drape, and the adherence caused the previously opened portion to shift/move and change the location of the sterile field.Medline contacted the customer and requested additional information, reviewed the returned sample, sent the finished device alleged failure investigation form to the contract manufacturer, and performed analysis of complaint data; the sample was inspected and it was sticky and difficult to open, the contract manufacturer review found no abnormalities or defects in their production, and complaint data analysis determined that there is no trend.Based on the results of the investigation, medline was able to confirm the complaint issue.Medline was unable to determine the root cause of the issue with the returned sample, and concluded that no further investigation into the cause and complaint is warranted and that the complaint will be reopened, updated, and investigated as necessary if additional information 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,FEMORAL ANGIOGRAPHY,2 WND,ST,20/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50772520
• Report Number: 1417592-2026-40418
• Device Sequence Number: 13133740
• Product Code: PUI
• UDI-Device Identifier: 10080196825479
• UDI-Public: 10080196825479
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/10/2026

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: 61425100336
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/16/2026
• 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: 02/24/2026
• 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