MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 1LYR ADD-A-CATH UM TRAY

Catalog Number	DYND160200
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foley slipping off drain tube from the add a cath kit but doesn¿t slip off drain tube from the single pull urine meter bag.
Additional Manufacturer Narrative
The customer reported foley slipping off drain tube from the add a cath kit but doesn¿t slip off drain tube from the single pull urine meter bag, with 8 occurrences within the past two weeks.Medline quality received 1 ea of the reported product in unpackaged, used condition; visual assessment revealed no defects nor abnormalities, and functional testing was conducted by disconnecting and reconnecting the catheter, pulling on the catheter to test the connection strength, and comparing to another urine meter on hand.The reported issue of catheter disconnections could not be verified based on visual or functional inspection of the received sample.Based on the assessment of the received sample and current complaint trends for this product and component lot, this complaint is unconfirmed.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: 1LYR ADD-A-CATH UM TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50853918
• Report Number: 1417592-2026-47413
• Device Sequence Number: 9497709
• Product Code: OHR
• UDI-Device Identifier: 10884389118733
• UDI-Public: 10884389118733
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/21/2026

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: DYND160200
• Device Lot Number: 25BBC202
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2025
• 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: 07/22/2025
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (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