MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, TIEMANN; CATHETER, RETENTION TYPE, BALLOON

Catalog Number 171305-000180

Device Problem Material Rupture (1546)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/11/2022

Event Type  malfunction  

Event Description

The bladder contained 620cc.Catheter size 16 was inserted, the balloon was inflated at 10cc.In the next minute the balloon self-deflated and self-expelled.So the patient was re-catheterized with a catheter from the same lot#.The same issue occurred, the balloon self-deflated and self-expelled.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.

Manufacturer Narrative

Qn# (b)(4).The device lot number was not provided; therefore a dhr review could not be conducted.There was no complaint device returned for investigation.Based on the complaint description, it was reported that the catheter's balloon is deflating which suggest that the balloon had leak.In the absence of any actual or representative sample for investigation, further investigation could not be conducted to identify the actual root cause of this reported failure.Therefore, this complaint could not be confirmed.

Event Description

The bladder contained 620cc.Catheter size 16 was inserted, the balloon was inflated at 10cc.In the next minute the balloon self-deflated and self-expelled.So the patient was re-catheterized with a catheter from the same lot#.The same issue occurred, balloon self-deflated and self-expelled.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, TIEMANN
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15266527
• MDR Text Key: 304216936
• Report Number: 8040412-2022-00254
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 171305-000180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2022
• 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
• Treatment: N/A.