MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL

Catalog Number 170605-000140

Device Problem Deflation Problem (1149)

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

Event Date 12/23/2021

Event Type  malfunction  

Event Description

Patient was catheterized.The balloon deflated 10 hours after catheterization.Once out of the patient the balloon was checked and the balloon is leaking.Clinical consequence: the patient was re-catheterized.

Manufacturer Narrative

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

Event Description

Patient was catheterized.The balloon deflated 10 hours after catheterization.Once out of the patient the balloon was checked and the balloon is leaking.Clinical consequence: the patient was re-catheterized.

Manufacturer Narrative

(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.Therefore, no physical assessment could be conducted, and an investigation was based on document review.In the absence of any actual or representative sample for investigation, we could not further investigate to identify the actual root cause of this reported failure.Therefore, this complaint could not be confirmed.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• 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: 13098558
• MDR Text Key: 285232161
• Report Number: 8040412-2021-00347
• 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: 12/24/2021

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: 170605-000140
• Device Lot Number: KME20J3327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 02/08/2022
• 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