MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. Medline Industries, Inc.; Foley Catheter Kit (Excludes Hiv Testing)

Model Number	URO175716
Medical Device Problem Codes	Material Rupture (1546); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Found catheter lying in the patient's bed while providing wound care.Upon inspection, the balloon appeared to have popped, causing the catheter to fall out.

• Brand Name: Medline Industries, Inc.
• Common Device Name: Foley Catheter Kit (Excludes Hiv Testing)
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 12001 general milton drive; laredo TX 78045
• MDR Report Key: 50816789
• Report Number: 50816789
• Device Sequence Number: 18811617
• Product Code: PPB
• UDI-Device Identifier: 10193489987423
• UDI-Public: (01)10193489987423
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/10/2026
• Report Date (Section F): 09/10/2026

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 Model Number: URO175716
• Device Catalogue Number: URO175716
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 128 LB
• Date Report Sent to FDA: 09/10/2026