MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRAPE,ANESTHESIA,SPLIT,CVMAX ,CLR,6/CS

Catalog Number	DYNJP4013
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drape is coming apart where the drape and the plastic are joined together at the top.
Additional Manufacturer Narrative
The customer reported that the drape is coming apart where the drape and the plastic are joined together at the top.A sample and/or photo was requested by the customer; however, the customer was unable to provide either a sample or photo, and samples from the local distribution branch were inspected; the branch provided samples met product specifications for size and materials, the seam did pull apart easily if intentionally pulled up on the material at the seam, but the issue was unable to be duplicated when it was draped out.Based on the results of the investigation the issue is confirmed, and the vendor investigation determined two possible causes: human error, the adhesive was not applied correctly, and the double-sided tape used may not have been strong enough and was not inspected prior to use.There was no reported death or serious injury associated with this event, no further investigation into the cause and complaint is warranted, and 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,ANESTHESIA,SPLIT,CVMAX ,CLR,6/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50615698
• Report Number: 1417592-2026-32615
• Device Sequence Number: 10573479
• Product Code: PUI
• UDI-Device Identifier: 10080196287291
• UDI-Public: 10080196287291
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/02/2026

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: DYNJP4013
• Device Lot Number: 11024100360
• Was Device Available for Evaluation?: No
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown