MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH 3W 30ML 100% SILICONE STR H 22; CATHETER, RETENTION TYPE, BALL

Catalog Number 173830220

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Two patients affected; 3-way catheters placed in operating room.Both incidents occurred on the same date.The first patient was assisted to the bedside commode and when assisted back to bed it was noted that the 3-way foley catheter came out with fluid on the flood and the balloon was deflated.The balloon was checked, and it was found to be leaking.Additional 3-way foley catheter was placed a few hours later.Rusch silicone 3-way catheter balloon, 30cc.Lot#ngfz2375 was leaking.

Event Description

Two patients affected; 3-way catheters placed in operating room.Both incidents occurred on the same date.The first patient was assisted to the bedside commode and when assisted back to bed it was noted that the 3-way foley catheter came out with fluid on the flood and the balloon was deflated.The balloon was checked, and it was found to be leaking.Additional 3-way foley catheter was placed a few hours later.Rusch silicone 3-way catheter balloon, 30cc.Lot#ngfz2375 was leaking.

Manufacturer Narrative

Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed and 100% leak test was conducted and no leak product was found.1 piece of actual sample was returned for investigation.Based on the complaint description, it was reported that the balloon leaked, and the catheter slipped out of the bladder.Visual examination was conducted on the actual sample and observed that there was no abnormality or design irregularity observed on the returned sample.The balloon was then inflated using water to identify the leak point.As water was injected into inflation channel of the catheter, the water was seen slowly seeping out from a small opening at the balloon surface.Close examination under high magnification lens (50x magnification) revealed that there was clear cut mark at the balloon surface.Based on picture 3 above, there were clear cut mark observed on the balloon surface.The presence of clear-cut marks may occur due to several reasons such as in contact with sharp or pointed object during handling that render the balloon to leak.In our current standard operating procedure, the products are subjected to 100% visual inspection and any defective raw balloon will be culled out before sent to the next process.Upon completion of assembly process, the finished catheter will be again subjected to 100% balloon inspection and 20 minutes leak test.Catheter with defective balloon will be culled out during this process.

• Brand Name: RUSCH 3W 30ML 100% SILICONE STR H 22
• Type of Device: CATHETER, RETENTION TYPE, BALL
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15506866
• MDR Text Key: 305620719
• Report Number: 8040412-2022-00278
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

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 Operator: Health Professional
• Device Catalogue Number: 173830220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1