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

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.

Manufacturer Narrative

(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

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.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, TIEMANN
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 12459587
• MDR Text Key: 272137629
• Report Number: 8040412-2021-00232
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

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: 171305-000200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 09/13/2021
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1