MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BAG,LEG,TWIST-VALVE,STRAPS,LARGE,32OZ

Catalog Number	DYND12578H
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the leg bags received leak and have visual holes on the inside of them.
Additional Manufacturer Narrative
Rep emailed in on behalf of the account advising that the leg bags received leak and have visual holes on the inside of them.Medline quality did not receive a sample nor photographs of the reported product, and did not receive the lot information; the account response stated that the bags were thrown out and covered in urine.The issue is unconfirmed, as no samples nor photographs were made available to review.A root cause cannot be identified at this time; medline quality will continue to monitor for the issue through weekly complaint meetings and monthly trending analysis, and if a product is received or more information is made available, the complaint will be reopened and an investigation will be performed.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,LEG,TWIST-VALVE,STRAPS,LARGE,32OZ
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50819021
• Report Number: 1417592-2026-44700
• Device Sequence Number: 10677669
• Product Code: KNX
• UDI-Device Identifier: 10080196990320
• UDI-Public: 10080196990320
• 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): 09/17/2026

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: DYND12578H
• 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: 09/08/2023
• Initial Report FDA Received Date: 09/18/2026
• 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