MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 2-TIER BTC,12/CS

Catalog Number	DYNJP2TBTC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we had a hole in our two-tiered drape today.".
Additional Manufacturer Narrative
The customer reported a hole in the two-tiered drape.Medline reviewed the complaint history and nonconformance trends for this product and this customer for the past 24 months, and the sample was reviewed; there was tear along the top tier pe material of the drape.The issue is confirmed, and medline was unable to determine the root cause of the tear.At this time medline will monitor for trending, 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: 2-TIER BTC,12/CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shravan ingole ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50755997
• Report Number: 1417592-2026-39505
• Device Sequence Number: 9414894
• Product Code: PUI
• UDI-Device Identifier: 20888277729404
• UDI-Public: 20888277729404
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/08/2026

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: DYNJP2TBTC
• Device Lot Number: 10888277729407
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2024
• 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: 07/10/2024
• Initial Report FDA Received Date: 09/14/2026
• 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