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

Catalog Number 170605-000160

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2019

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 there was a leak of the balloon.Despite the fact that we re-inflated the balloon, the leak remained.Clinical consequences: discomfort for the patient.

Event Description

It was reported that there was a leak of the balloon.Despite the fact that we re-inflated the balloon, the leak remained.Clinical consequences: discomfort for the patient.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspection.2 pieces of representative samples were returned for investigation.Based on the complaint description, it was reported that there was a leak of the balloon.Investigation was performed on the representative samples by inflating each balloon with l0ml of sterile water.After 20 minutes, both samples could stay inflate with no issue and no leak was observed.Both catheters were also observed to have no issue during deflation.Leak balloon may happen due to several reasons such as in contact with sharp object during use i.E.Contact with clamper, kidney dish/tray , overinflating or contact with contradict lubricants such as oil based antiseptic phenols or their derivatives, grease, petroleum jelly , petroleum spirit, paraffin or other relative compounds.Balloon could also leak because of balloon had encounter bladder or kidney stone during use for patient with bladder or kidney stone history.In our current standard operating procedure, the raw balloons 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 several reasons.However, based on the representative samples returned, no deflation or leak issue observed , therefore this complaint could not be confirmed.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 9395783
• MDR Text Key: 175701992
• Report Number: 8040412-2019-00357
• 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,u
• Type of Report: Initial,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Catalogue Number: 170605-000160
• Device Lot Number: 19DE14
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1