MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH FOLEY SILICONE 3W 30ML; CATH., RETENTION, BALLOON

Catalog Number	173830200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "item broke in a patient's bladder.The prostate surgery was over, [physician] had just installed the urinary catheter in the patient's bladder.A few seconds after installation, the catheter removed itself and we visualized the burst balloon as in the attached photo.Debris from the balloon could have remained in the patient's bladder." no patient consequences or harm were reported.
Event or Problem Description
It was reported that "item broke in a patient's bladder.The prostate surgery was over, [physician] had just installed the urinary catheter in the patient's bladder.A few seconds after installation, the catheter removed itself and we visualized the burst balloon as in the attached photo.Debris from the balloon could have remained in the patient's bladder." no patient consequences or harm were reported.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: RUSCH FOLEY SILICONE 3W 30ML
• Common Device Name: CATH., RETENTION, BALLOON
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22290233
• Report Number: 8040412-2025-00175
• Device Sequence Number: 12980779
• Product Code: EZL
• UDI-Device Identifier: 04026704334865
• UDI-Public: (01)04026704334865(11)240805(17)290731(10)40E24H0744(21)
• Combination Product (Y/N): N
• PMA/510(K) Number: K972184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 173830200
• Device Lot Number: 40E24H0744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Male