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

Catalog Number 171305-000180

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 02/17/2020

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

It was reported that for a (b)(6)-year-old patient, (b)(6) kg.There was leakage of the catheter.Happened with 4 patients.The product manager stated that it is not an incident due to the devices but an incident due to the age of the patients.Information was provided on (b)(6) 2020 to customer to inform about issues that can occur with old patients (bladder neck distends).The leakage would be due to an anatomic reason where the seal cannot be performed the same way for very old patients and younger patients.The opinion of the product managers was just provided as a simple opinion that would have may helped for the investigation.

Event Description

It was reported that for a 96-year-old patient, 72.8 kg.There was leakage of the catheter.Happened with 4 patients.The product manager stated that it is not an incident due to the devices but an incident due to the age of the patients.Information was provided on 20 january 2020 to customer to inform about issues that can occur with old patients (bladder neck distends).The leakage would be due to an anatomic reason where the seal cannot be performed the same way for very old patients and younger patients.The opinion of the product managers was just provided as a simple opinion that would have may helped for the investigation.

Manufacturer Narrative

(b)(4).The device lot number was not provided; therefore, a dhr review could not be conducted.Due to limited information and no sample returned available for investigation, it is difficult to determine the real root cause of the failure whether it is due to product malfunction or an incident related to patient.In the absence of the returned sample and limited information available on this complaint, further investigation to determine actual root cause of the problem reported could not be determined.Therefore, this complaint could not be confirmed.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, TIEMANNBRILLANT 2
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 9823961
• MDR Text Key: 186332478
• Report Number: 8040412-2020-00075
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

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: 171305-000180
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 04/01/2020
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 96 YR
• Patient Weight: 72