MAUDE Adverse Event Report: TELEFLEX MEDICAL BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL; CATHETER, RETENTION TYPE, BALLOON

Catalog Number 170605-000160

Device Problem Deflation Problem (1149)

Patient Problem Burning Sensation (2146)

Event Date 06/19/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "the catheterized patient felt liquid coming out of the catheter.He informed the nurse who then tested the resistance of the catheter to make sure catheter was not self-expelling.When testing the balloon, the nurse failed to remove the sterile water and there was a resistance in the syringe.2 different nurses tried.The surgeon tried also.The urologist advised to remove the catheter".Further information states that the catheter "self-expelled".No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The manufacturing site reports "in current standard operating procedure as per (b)(4), the balloons are subjected to 100% visual inspection and any defective raw balloon will be discarded before sent to the next process.Upon completion of assembly process, the finished catheter will be again subjected to 100% balloon inspection, 20 minutes leak test and 100% deflation process.Catheter with defective balloon will be culled out during this process." 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.

Event Description

It was reported that "the catheterized patient felt liquid coming out of the catheter.He informed the nurse who then tested the resistance of the catheter to make sure catheter was not self-expelling.When testing the balloon, the nurse failed to remove the sterile water and there was a resistance in the syringe.2 different nurses tried.The surgeon tried also.The urologist advised to remove the catheter".Further information states that the catheter "self-expelled".No patient harm or injury.The patient status is reported as "fine".

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17317493
• MDR Text Key: 319328173
• Report Number: 8040412-2023-00273
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170605-000160
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2023
• 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: Initial
• Patient Sequence Number: 1