MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; FOLEY CATHETER KIT (EXCLUDES HIV TESTING)

Model Number	URO175816TS
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event 1 [date redacted] lot: 0332405a194 patient had indwelling foley catheter with temperature sensing probe.Around 12:50pm urine was noted to be on the floor underneath the foley catheter bag.Drops of urine were noted to be falling from the bag onto the floor from the side seam of the bag in the bottom corner.Lot number on foley bag = 0332405a194 event 2 [date redacted] lot: (10)25cbd894, gtin:(b)(4).Pa-c [certified physician's assistant] was preparing to place a temp sensing foley into a patient preoperatively when noticed that the balloon port was missing off the catheter.It was a manufacturing defect completely sliced off and missing.This foley was discarded (but saved for return) prior to use.Another opened and inserted without incident.Pa-c's attention to detail saved the patient from having multiple insertions.Manufacturer response for foley catheter, temperature sensing foley catheter (per site reporter).Event 1: [date redacted] sample collected and emailed [redacted]; [date redacted] mailed on fedex, no tracking #.Event 2: [date redacted] sample collected from [redacted] and mailed on fedex.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: FOLEY CATHETER KIT (EXCLUDES HIV TESTING)
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 22478305
• Report Number: 22478305
• Device Sequence Number: 12766486
• Product Code: PPB
• UDI-Device Identifier: 10193489988512
• UDI-Public: (01)10193489988512
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2025
• Report Date (Section F): 06/20/2025

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 Model Number: URO175816TS
• Device Catalogue Number: URO175816TS
• Device Lot Number: 0332405A194
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/20/2025