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

Catalog Number	URO170200
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "today, i had a third foley kit come apart where the catheter connects to the bag." it was also reported that "it happened twice last week" and "today, it came apart during our case in room "[room # redacted]" and also in room "[room # redacted]".".
Additional Manufacturer Narrative
Medline quality received a complaint regarding the catheter disconnecting from the urine meter with respect to the total one-layer add-a-cath tray with 400 ml urine meter with 2,500 ml drain bag, peri wipe (uro170200); according to the facility, the foley kit came apart where the catheter connects to the bag, and no medical intervention, serious injury, or follow-up care has been reported.Medline quality did not receive a sample nor photographs of the reported product, this product is an add-a-cath tray and does not include a catheter inside the kit, and it was not reported which catheter was being used with the urine meter; a review of the device history records and inspection records for the reported item found no similar issues noted, and a post-market retrospective review of the past 6 months preceding the reported issue revealed 0 additional complaints of drain bag connection issues with respect to uro170200.The issue is unconfirmed, as no samples nor photographs were made available to review, and a root cause cannot be identified at this time.Based on the findings of the quality investigation, no change has been made to the regulatory reportability decision for the complaint, 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: 1LYR ADD-A-CATH UM TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kurian jokutty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945759
• Report Number: 1417592-2026-54136
• Device Sequence Number: 10429125
• Product Code: OHR
• UDI-Device Identifier: 20888277410968
• UDI-Public: 20888277410968
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• 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: URO170200
• Device Lot Number: 24BBD370
• 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: 08/12/2024
• Initial Report FDA Received Date: 09/30/2026
• 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