MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY CAUTI TEMP SENS 16FR 10ML

Catalog Number	URO170816TSQ
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foley balloon burst while patient was sitting in chair.
Additional Manufacturer Narrative
According to the facility, "the foley balloon burst when the patient was sitting in a chair"; no harm was noted, no intervention was required, and patient output is being monitored.Medline quality received 1 ea of the reported product in unpackaged, used condition; visual assessment revealed a longitudinal tear in foley balloon, and functional testing by attempting to inflate the balloon to maximal volume noted that sterile water leaked immediately from the site of the tear.The reported issue was verified by visual assessment of the provided sample, and returned product evaluation confirmed foley catheter balloon rupture.The cause code was changed to cannot determine cause with received sample; the catheter is a supplier manufactured component, no medline handling or distribution factors were identified, supplier investigation and testing did not identify a definitive manufacturing defect, and the issue will continue to be monitored through complaint trending.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: TRAY CAUTI TEMP SENS 16FR 10ML
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdulrahim ghaffar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50772749
• Report Number: 1417592-2026-40464
• Device Sequence Number: 9488440
• Product Code: OHR
• UDI-Device Identifier: 40193489723428
• UDI-Public: 40193489723428
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/15/2026

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: URO170816TSQ
• Device Lot Number: 592220310
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/23/2023
• 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: 05/10/2023
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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