MAUDE Adverse Event Report: TELEFLEX MEDICAL 100%SILICONE 2WAY 5CC 18F

Catalog Number 170605180

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Alleged event: the catheter balloon leaked causing the device to come out of the patient.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).A device history report (dhr) was reviewed and no issues that could have contributed to the reported failure were noted.The device was manufactured according to release specifications.There was no complaint sample returned for investigation.However, a simulation test was conducted with representative samples from production on the same catheter size and balloon volume.Samples were inflated with 10ml distilled water and soak in water at 37 c for 7 days.Samples were removed from soaking after 7 days and check for any leakage.No deflation issue was observed; balloons were still inflated to its normal condition and shape.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.In the absence of sample returned, further investigation could not be conducted and therefore; complaint is not confirmed.

Event Description

Alleged event: the catheter balloon leaked causing the device to come out of the patient.The patient's condition was reported as fine.

• Brand Name: 100%SILICONE 2WAY 5CC 18F
• 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: 5331839
• MDR Text Key: 35059949
• Report Number: 8040412-2015-00257
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/09/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 170605180
• Device Lot Number: 15GE27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2016
• 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