MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SHEET,DRAPE,40X58,STERILE

Catalog Number	DYNJP2410
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have experienced sterile field contamination due to fluids penetrating through the (b)(6) half-drape.".
Additional Manufacturer Narrative
The customer reported that the (b)(6) does not work for their needs and stated that the drapes were "not completely sealed/impermeable" and dye "passed through onto the table underneath the drape." the customer was contacted and requested to provide additional information; samples were reviewed, 14 each of the (b)(6) were received, the samples were measured and met product specifications, and the (b)(6) has an aami level 1 rating.Based on the results of the investigation, medline was unable to confirm the complaint issue or that the product failed to meet specifications.This is a customer preference issue and needs a high-level aami rated drape, and no trend was identified.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: SHEET,DRAPE,40X58,STERILE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50853804
• Report Number: 1417592-2026-47390
• Device Sequence Number: 9936607
• Product Code: PUI
• UDI-Device Identifier: 10080196739691
• UDI-Public: 10080196739691
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/17/2026

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: DYNJP2410
• Device Lot Number: 11025080457
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2026
• 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: 02/12/2026
• Initial Report FDA Received Date: 09/22/2026
• 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