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 12/11/2017

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).The batch card(s) for the complaint lot(s) was reviewed all samples passed qa inspection.The actual sample was returned for investigation.Based on complaint description, it was reported the balloon could not inflate and also balloon had leak.Visual examination was conducted on the returned sample and observed that there were no abnormalities or design irregularities observed on the catheter.Investigation was conducted on the actual returned sample by inflating and deflating using plain water and observed that the balloon can be inflate and deflate without any issues.Difficult to inflate/deflate balloon could be due to various reasons such as leak balloon, faulty valve, incompatible syringe or blocked lumen or funnel.However, there was no issue with the valve and its functionality as the balloon was able to inflate and deflate with no restriction felt.While leak balloon may happen due to various reasons such as contact with sharp object during use i.E contact with clamper, kidney dish/tray, overinflating or contact with contradict other remarks: 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 balloon may have come in contact with bladder or kidney stone history.In our current standard operating procedure, upon completion of assembly process, the finished catheters were subjected to the 100% balloon inspection and leak test.Based on the investigation conducted, the returned sample was able to inflated and deflated without any issue and there was no resistance felt and the valve in the catheter is able to function as per intended.Therefore this complaint could not be confirmed.

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: 7148621
• MDR Text Key: 96030354
• Report Number: 8040412-2017-00265
• 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: 01/23/2018
• Supplement Dates FDA Received: 01/23/2018
• 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