MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BAG,DRAINAGE,4L,A/R TOWER,METAL CLAMP

Catalog Number	DYND15405
Medical Device Problem Codes	Crack (1135); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the blue rubber hose connector has visible holes and looks weathered/worn out.".
Additional Manufacturer Narrative
The customer reported that the blue rubber hose connector has visible holes and looks weathered/worn out; the issue did not occur during use and no injury occurred.Medline quality received 2 ea of the reported product; 1 ea was received in packaged, unused condition and 1 ea was unpackaged but unused, and visual assessment revealed that the blue rubber tubing on both samples had cracks along the outlet tubes.Functional testing was conducted by filling the bags with water and observing for leakage at the rubber tubing while the metal clamps were shut; the rubber tubes showed no signs of leakage, and no functional defects were observed with the tubing or drainage clamps.The reported issue was verified by the sample evaluation; the vendor found no evidence of non-conformance in the product¿s manufacturing process and could not identify the root cause, and the complaint was closed as "defect confirmed: unknown responsible party: cannot determine cause w/received sample." 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: BAG,DRAINAGE,4L,A/R TOWER,METAL CLAMP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50941679
• Report Number: 1417592-2026-53973
• Device Sequence Number: 10756349
• Product Code: KNX
• UDI-Device Identifier: 10080196993406
• UDI-Public: 10080196993406
• 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): 09/28/2026

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: DYND15405
• Device Lot Number: 96924100002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/03/2025
• 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: 09/08/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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