MAUDE Adverse Event Report: TELEFLEX MEDICAL BRILLANT 100% SIL FOLEY 16FR

Catalog Number 170605-000160

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2018

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

It was reported that for a (b)(6) years old patient after a maternity intervention.The catheter did not empty.It was checked visually and there was no kink or clot.There was urinary retention; the catheter was replaced urgently.

Event Description

It was reported that for a 45 years old patient after a maternity intervention.The catheter did not empty.It was checked visually and there was no kink or clot.There was urinary retention; the catheter was replaced urgently.

Manufacturer Narrative

Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed all samples passed qa inspection.An actual sample was returned for investigation and show no obvious abnormality upon visual inspection.The sample was subjected for inflation test using water according to its required balloon capacity.The balloon was inflated successfully without any difficulty.The balloon was then subjected for deflation test with no issue at all.Non-deflation could be due to several reasons such as improper fixation of syringe to the valve, faulty valve and blockage of inflation lumen.In a standard practice, an empty syringe without plunger is also recommended to be used to drain off the fluid by gravity and avoid creation of vacuum effect and ease deflation process.Besides that, based on the ifu, it was advice to cut the shaft near the entry site as to allow the liquid to flow out of the balloon if the valve fails to deflate the balloon.Other remarks: in our current standard operating procedure, the products are subjected to 100% visual and any defective raw balloon will be discarded before sent to the next process.Upon completion of assembly process, the finished catheter will be again subjected to 100% balloon inspection, 20 minutes leak test and 100% deflation process.Catheter with defective balloon will be culled out during this process.Balloon could not be deflated may due to several reasons.However, the returned sample shows no issue during investigation per claimed.Therefore, this complaint could not be confirmed.Additional method code: 26.

• Brand Name: BRILLANT 100% SIL FOLEY 16FR
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• MDR Report Key: 7392960
• MDR Text Key: 104422360
• Report Number: 8040412-2018-00093
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

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: 170605-000160
• Device Lot Number: 17KE46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Initial Date Manufacturer Received: 03/28/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR