MAUDE Adverse Event Report: TELEFLEX MEDICAL BRILLANT 100% SIL FOLEY 18FR; CATHETER, RETENTION TYPE, BALL

Catalog Number 170605160

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2019

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 during insertion of the catheter, the nurse managed to evacuate a major urine retention but had difficulty inflating the balloon.After pushing 5cc it stopped.The catheter was removed.The balloon was not tested prior to use.There was no serious patient injury.

Event Description

It was reported that during insertion of the catheter, the nurse managed to evacuate a major urine retention but had difficulty inflating the balloon.After pushing 5cc it stopped.The catheter was removed.The balloon was not tested prior to use.There was no serious patient injury.

Manufacturer Narrative

Qn#(b)(4).The device lot number was not provided; therefore , a dhr review could not be conducted.There was one piece of representative sample returned for investigation but only the proximal part of the catheter was received.Based on the complaint description, it was reported that the nurse managed to evacuate a major urine retention but had difficulty to inflate the balloon.Non-inflation could be due to various reasons such as leak balloon, faulty valve, faulty syringe, improper syringe insertion or blocked lumen or funnel.Investigation was conducted by inflating the inflation lumen of the proximal part of the catheter with red color water.However, there was no blockage or leak found along the lumen which resulted in non-inflation.The red color water was successfully flow through the inflation lumen.However, further investigation could not be conducted since the returned sample was incomplete.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.Non-inflation balloon may due to several reasons.However, the returned sample was incomplete and after investigation there was no blockage or leak which may result in non-inflation encountered during testing.Therefore, this complaint could not be confirmed.

• Brand Name: BRILLANT 100% SIL FOLEY 18FR
• Type of Device: CATHETER, RETENTION TYPE, BALL
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• MDR Report Key: 8281291
• MDR Text Key: 134335633
• Report Number: 8040412-2019-00039
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K972184
• 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: 01/09/2019

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: 170605160
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/28/2019
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1