MAUDE Adverse Event Report: TELEFLEX MEDICAL 100%SILICONE 2WAY 5CC 16FR

Catalog Number 170605160

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Alleged event: the catheter was found broken between the connection and the tip used to inflate the balloon.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The device history review did not show issues related to the complaint.The visual examination of the sample showed that the catheter was broken in two parts.The sample was aligned and the total length was measured and met the specifications for this product.Both the shaft and the funnel were examined using the dino-lite to analyze the damaged area and torn edges.It was observed that the torn edges were jagged and there was excessive material at one side indicating that there is some external force applied at the joint area causing the catheter to break.The funnel portion revealed some cutting edges suggesting that the tube was once well attached to the funnel.No other nicks, abrasion, marks, or scratches were observed on the embedded shaft that could have likely caused the breakage.Other remarks: the manufacturer performed positive released tests at the injection molding process with representative samples using weight load testing to test the bonding strength between the funnel and tube prior to release.Based on the investigations no problem was found within the product which could have contributed from manufacturing processes.Therefore this complaint could not be confirmed.The root cause is unknown.The manufacturer will continue to monitor and trend related events.

• Brand Name: 100%SILICONE 2WAY 5CC 16FR
• 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: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 5510786
• MDR Text Key: 40948935
• Report Number: 8040412-2016-00058
• Device Sequence Number: 1
• Product Code: FGH
• 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: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 170605160
• Device Lot Number: 15CE13
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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