MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRAPE,LAPAROTOMY,T-SHEET,ST,12/CS

Catalog Number	DYNJP3003
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there was about a 1.5 inch cut in the laparotomy t-drape item #dynjp3003.".
Additional Manufacturer Narrative
The customer reported about a 1.5 inch cut in the laparotomy t-drape, and the issue did not occur during use.A sample and photo were returned by the customer; the photo shows the device with a tear on the drape, and the sample was not in its original packaging and had an approximately one inch cut in the drape that went through multiple layers.A review of the contract manufacturer records, manufacturing process, and retained samples found no abnormalities or defects in their production, and analysis of complaint data determined there is no trend.Based on the results of the investigation, the complaint issue was confirmed and the product failed to meet specifications; the root cause of the cut could not be determined, 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,LAPAROTOMY,T-SHEET,ST,12/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: 50772886
• Report Number: 1417592-2026-40486
• Device Sequence Number: 10528975
• Product Code: PUI
• UDI-Device Identifier: 10080196723140
• UDI-Public: 10080196723140
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: DYNJP3003
• Device Lot Number: 85825072352
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/30/2026
• 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: 01/20/2026
• 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