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

Catalog Number 171305-000200

Device Problems Tear, Rip or Hole in Device Packaging (2385); Material Split, Cut or Torn (4008)

Patient Problems Insufficient Information (4580); 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 an 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.

Event Description

We had an information from our distributor that, he sold the 171305-000200 to (b)(4) 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

Qn#(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.In the absence of any actual or representative sample for investigation, further investigation could not be conducted to identify the actual root cause of this reported failure.Therefore, this complaint could not be confirmed.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspection.There are 63 pieces of representative sample returned for investigation.Based on complaint description the doctors 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.All 63 pieces representative samples were visually inspected, and no abnormality found.The samples then inflated with 10ml distilled water and no leak balloon observed.In current standard operating procedure, according to spm-asl-003 the products are subjected to 100% visual inspection and any defective raw balloon will be culled out before sent to the next process.Upon completion of assembly process, as per spm-a52-004 the finished catheter will be again subjected to 100% balloon inspection and 20 minutes leak test.Catheter with defective balloon will be culled out during this process.There was no abnormalities or design irregularities observed on the returned representative sample.The sample also can be inflated with no leak balloon issue observed.Post 14 days of soak test it was determine the catheter not showing any balloon burst or leak.Therefore, this complaint could not be confirmed.

Event Description

We had an 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
• 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: 12533481
• MDR Text Key: 281340247
• Report Number: 8040412-2021-00233
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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,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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 10/27/2021; 03/02/2022
• Supplement Dates FDA Received: 11/01/2021; 03/18/2022
• 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