MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRAPE,PROCEDURE,SPECIAL,ST,18/CS

Catalog Number	DYNJP4105
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there is no adhesive on the drape other than the part that covers the actual opening of the drape.The drape should have an open hole with adhesive around the hole.".
Additional Manufacturer Narrative
The customer reported that the adhesive covered the opening of the drape.The customer was contacted and requested to provide additional information, the sample was reviewed, and the openings were covered with adhesive; the contract manufacturer performed an investigation at their facility.Based on the results of the investigation, medline was able to confirm the complaint issue and that the product failed to meet specifications.The contract manufacturer determined that they were provided incorrect product specifications, and based on the investigation results, 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,PROCEDURE,SPECIAL,ST,18/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rylee rosenberg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50545175
• Report Number: 1417592-2026-29431
• Device Sequence Number: 10651343
• Product Code: PUI
• UDI-Device Identifier: 10080196736362
• UDI-Public: 10080196736362
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/31/2026

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: DYNJP4105
• Device Lot Number: 21225070027W
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/22/2025
• 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: 12/11/2025
• Initial Report FDA Received Date: 09/01/2026
• 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