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

Catalog Number 171305-000200

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 09/09/2021

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 we had information from our distributor that he sold the 171305-000200 to 3 doctors and they noticed that the catheter moved its position two or three days after the placement and a slit in the balloon was observed during the inspection of the product but there was zero harm for the patient.Following our email yesterday.Today i had a meeting with our distributor who informed us yesterday about the problem with our catheters, which he had sold to a doctor with code 171305-000200.They informed me that in a communication with the doctor he informed them that in four different patients who placed the 171305-000200 catheter after 1-2 days the balloon collapsed , and the catheter was moved from its position (noticing a small slit in the balloon).They assured me that none of the patients had any complications and the doctor chose to make the change with a smaller size with our own catheter code 171305-000180 without repeating the same to any of the patient's incident after change.

Manufacturer Narrative

Qn#(b)(4).A device history record (dhr) review could not be conducted since the lot number was not provided.No sample was returned for investigation; therefore, no physical assessment could be conducted.Balloon split could happen due to various 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.

Event Description

Customer reported that we had information from our distributor that he sold the 171305-000200 to 3 doctors and they noticed that the catheter moved its position two or three days after the placement and a slit in the balloon was observed during the inspection of the product but there was zero harm for the patient.Following our email yesterday.Today i had a meeting with our distributor who informed us yesterday about the problem with our catheters, which he had sold to a doctor with code 171305-000200.They informed me that in a communication with the doctor he informed them that in four different patients who placed the 171305-000200 catheter after 1-2 days the balloon collapsed , and the catheter was moved from its position (noticing a small slit in the balloon).They assured me that none of the patients had any complications and the doctor chose to make the change with a smaller size with our own catheter code 171305-000180 without repeating the same to any of the patient's incident after change.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, TIEMANN
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 12514940
• MDR Text Key: 273767483
• Report Number: 8040412-2021-00251
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 171305-000200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1