MAUDE Adverse Event Report: TELEFLEX MEDICAL BRILLANT 100% SIL FOLEY 14FR

Catalog Number 170605-000140

Device Problems Burst Container or Vessel (1074); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

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 the catheter was inserted and three days later the catheter was found out of the patient with the balloon fully deflated.While checking the balloon, it was noticed that the balloon had two holes in it.During the pre-test there was no hole.There was no patient injury.

Event Description

It was reported that the catheter was inserted and three days later the catheter was found out of the patient with the balloon fully deflated.While checking the balloon it was noticed that the balloon had two holes in it.During the pre-test there was no hole.There was no patient injury.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed all samples passed qa inspection.Three representative samples was returned for investigation.Based on visual inspect ion, there was no abnormality observed on the samples.Investigation was conducted on the returned samples by inflated and deflated the balloon catheter using colored water and observed that the balloon can be inflated and deflated without any issue.There was no abnormalities or design irregularities observed on the returned samples as per stated by complainants.Leak balloon/cuff may occur due to various reasons such as in contact with sharp or pointed objects or exposure to encrustation which causes leak to the balloon.This will cause balloon not able to stay inflated.However, without actual sample returned for investigation, the actual root cause of this phenomenon could not be determined.In our current standard operating procedure, 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, 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.Leak balloon could happen due to various reasons.However, in the absence of the actual sample and limited information available on this complaint, further investigation could not be conducted and therefore complaint is not confirmed.

• Brand Name: BRILLANT 100% SIL FOLEY 14FR
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• MDR Report Key: 7656316
• MDR Text Key: 113197158
• Report Number: 8040412-2018-00172
• 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: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170605-000140
• Device Lot Number: 18AE02
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1