MAUDE Adverse Event Report: TELEFLEX MEDICAL BRILLANT 100% SIL FOLEY 1.5ML PED

Catalog Number 170003-000060

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the bladder catheters were difficult to inflate using aqua glycerin mixture.Afterwards, an ultrasound of the bladder was performed; it was seen that the balloon had been perforated.It was removed and a new device was inserted in the neonate.There was no reported patient injury.

Manufacturer Narrative

(b)(4).4 representative samples were returned for investigation.Based on the reported failure, the balloon was difficult to inflate.This phenomenon is known as non-inflation and could be due to several reasons such as leak balloon, faulty valve, faulty syringe, improper syringe insertion or blocked lumen or funnel.On different case, the balloon was claimed to deflate immediately after catheter insertion.This phenomenon is known as leak balloon.Leak balloon could be due to several reasons such as being 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.Investigation was performed on all the representative samples by inflating the balloon using 1.5m1 of air.After 20 minutes, all the samples could stay inflate with no issue.The catheter was also observed to have no issue during deflation.The samples were then inflated with 1.5m1 of water using a luer tip syringe and it was observed that the balloons are able to inflate another remained inflated when left idle for 20 minutes to its required size and shape without any issue in our other remarks: 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 and 20 minutes leak test.Catheter with defective balloon will be culled out during this process.Balloon could not be inflated could be due to several reasons.However, any non-inflation issue could not be found in the returned sample.Therefore, this complaint could not be confirmed.Leak balloon could happen due to several reasons.However, in the absence of returned sample and limited information available on this complaint, further investigation could not be conducted and therefore complaint is not confirmed.The batch card(s) for the complaint lot(s) was reviewed all samples passed qa inspection.

Event Description

It was reported that the bladder catheters were difficult to inflate using aqua glycerin mixture.Afterwards, an ultrasound of the bladder was performed; it was seen that the balloon had been perforated.It was removed and a new device was inserted in the neonate.There was no reported patient injury.

• Brand Name: BRILLANT 100% SIL FOLEY 1.5ML PED
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 7148598
• MDR Text Key: 96122267
• Report Number: 8040412-2017-00266
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

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: 170003-000060
• Device Lot Number: 17GE27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 01/26/2018
• 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: N
• Patient Sequence Number: 1