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

Catalog Number 171305-000140

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 12/16/2018

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

Customer reported that "on 14 and 15 december one patient received on the emergency (b)(6) a bladder catheter.These catheters came out with a broken balloon in both cases.On the 15.12.Patient received the same bladder catheter again in the evening at our station.This one slipped also out of patient again on 16.12.In the morning, because the balloon was broken again.I talked to the nf and they used the same catheters with the same batch number: 171305.Of course, we are aware that the problem could be related to the patient's bladder.We report it as a precaution, because there might also be a material problem.

Event Description

Customer reported that "on (b)(6) one patient received on the emergency sonnenhof a bladder catheter.These catheters came out with a broken balloon in both cases.On the 15.12.Patient received the same bladder catheter again in the evening at our station.This one slipped also out of patient again on 16.12.In the morning, because the balloon was broken again.I talked to the nf and they used the same catheters with the same batch number: 171305.Of course, we are aware that the problem could be related to the patient's bladder.We report it as a precaution, because there might also be a material problem.

Manufacturer Narrative

(b)(4).A device history record (dhr) review could not be conducted since the lot number was not provided.No physical investigation or assessment has been conducted on the defective catheter as no actual or representative sample was returned for investigation.Leak balloon could be due to several reasons.However, in the absence of returned sample and limited information available on this complaint, further investigation could not be conducted and therefore complaint is not confirmed.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, TIEMANN
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 9482504
• MDR Text Key: 183748008
• Report Number: 8040412-2019-00365
• 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,u
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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: 171305-000140
• Device Lot Number: UNKN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1