MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-CATH LAB BASIN PACK

Catalog Number	DYNJ69864C
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the staff is finding the blue or towels are fraying.
Additional Manufacturer Narrative
The account reported that the blue or towels are fraying, the issue occurred during use, and no injury was reported.No sample or photo was received for the investigation; finished good production records were reviewed and there were no line down situations, run without approvals, deviations, or non-conformance reports that might have had an impact on this issue, and finished good pack build was reviewed with no issues identified that would contribute to the reported concern.At this time, medline was unable to confirm the reported defect, as no physical sample and no detailed photographic evidence was provided to support the investigation; the cause was unconfirmed and a sample was required to determine cause.The division will monitor this issue for trending purposes.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: DBD-CATH LAB BASIN PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: daniel soto ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50755806
• Report Number: 1417592-2026-39466
• Device Sequence Number: 18482012
• Product Code: KDD
• UDI-Device Identifier: 10198459402432
• UDI-Public: 10198459402432
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/09/2026

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: DYNJ69864C
• Device Lot Number: 25JBE718
• 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: 12/04/2025
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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