MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH GOLD LATEX 2W 3ML PAED.; CATHETER, RETENTION TYPE, BALLOON

Catalog Number	180003-000080
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "the patient was scheduled for a catheter replacement, but the installed catheter balloon could not be deflated.Efforts to deflate the balloon were made by drawing out the balloon fluid using a 3cc syringe, a 10cc syringe, and cutting the catheter balloon valve, but the balloon could not be deflated.Therefore, the patient had to undergo a percutaneous cystostomy to deflate the balloon and remove the catheter so that a new catheter could be inserted.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).One (1) actual sample received for investigation.The lot number and finished good product code could not be verified as the packaging was not returned.Upon inspection of the sample returned, the catheter received already damaged as it was observed that the catheter balloon had burst, and inflation funnel with valve also had been cut and the cut portion was not included in the returned sample.Visual inspection conducted on the returned sample showed that there was no sign of kinking, clamp mark observed throughout the shafts of the catheter and no tear was observed at the inflation eye.However, it was observed that the lumen beneath the inflation eye was folded and collapsed.The inflation lumen was tested by introducing water through the inflation funnel, the water was able to flow through the lumen into the inflation eye without any obstruction or blockage.The device history record could not be performed due to lot number is unknown.Instructions for use have been reviewed.Under section potential complications "in case of undeflatable balloons cut the catheter shaft at the bifurcation or perforate the balloon according to established procedures.".Recommendation section "visually inspect the catheter for any mechanical damage and check for leaks before use.".Warning section mentioned "do not over inflate the balloons! excessive aspiration can collapse inflation lumen".Corrective action is not required as part of this complaint investigation as the sample was received in damaged condition and no kink or blockage observed on the returned catheter.There was collapsed lumen observed beneath the inflation eye however its impact on the reported non-deflation could not be confirmed due to the inability to perform functional testing.Based on the visual inspection of the returned sample, the catheter was received in damaged condition.The inflation funnel with valve had been cut, and the balloon burst.The cut inflation funnel with valve was not returned for investigation.The testing was performed on the returned catheter, and no abnormalities were identified; no kink, blockage and restriction was observed within the inflation lumen.However, due to the condition of the sample was damaged, a complete investigation to confirm the non-deflation could not be performed.Thus, the complaint could not be confirmed, and the corrective action is not required.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "the patient was scheduled for a catheter replacement, but the installed catheter balloon could not be deflated.Efforts to deflate the balloon were made by drawing out the balloon fluid using a 3cc syringe, a 10cc syringe, and cutting the catheter balloon valve, but the balloon could not be deflated.Therefore, the patient had to undergo a percutaneous cystostomy to deflate the balloon and remove the catheter so that a new catheter could be inserted.".

• Brand Name: RUSCH GOLD LATEX 2W 3ML PAED.
• Common Device Name: CATHETER, RETENTION TYPE, 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24742144
• Report Number: 8040412-2026-00039
• Device Sequence Number: 17211311
• Product Code: EZL
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 180003-000080
• Device Lot Number: 40A25C292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/14/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Weight: 40 KG