MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC; CATHETER, RETENTION TYPE, BALLOON

Catalog Number 170003-000100

Device Problem Deflation Problem (1149)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the clinician has noticed over the past couple of months there have been numerous catheters that they have had difficulty removing due to how the retention balloon deflates.They are attaching the syringe and allowing the balloon to deflate itself and not aspirating with the syringe, they have also tried refilling the balloon and allowing to deflate again however this makes little to no difference.The catheters are therefore difficult to remove and causing the patients a lot of pain, once removed they have noticed the balloon has deflated leaving a ridge around the whole diameter of the catheter.

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.

Event Description

It was reported that the clinician has noticed over the past couple of months there have been numerous catheters that they have had difficulty removing due to how the retention balloon deflates.They are attaching the syringe and allowing the balloon to deflate itself and not aspirating with the syringe, they have also tried refilling the balloon and allowing to deflate again however this makes little to no difference.The catheters are therefore difficult to remove and causing the patients a lot of pain, once removed they have noticed the balloon has deflated leaving a ridge around the whole diameter of the catheter.

• Brand Name: BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC
• Type of Device: 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15936201
• MDR Text Key: 306589746
• Report Number: 8040412-2022-00334
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170003-000100
• Device Lot Number: 8313406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2023
• 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: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED