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

Catalog Number 170605160

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported event: particles, filament or small pieces of silicon were found on several catheters of several lot numbers of size 16.All lot numbers concerned have been quarantined.The patient condition was reported as fine.

Manufacturer Narrative

(b)(4).Device history record batch card for the complaint lots were reviewed, and passed the qa inspection.Nine pieces of samples were returned for investigation.Based on complaint description, users have found particles of filament (or small pieces) of silicon in several catheters.Returned samples were carefully review using naked eye showing no abnormality.All other components were intact and in good condition other than the presence of small pieces of silicone along the catheter.Two samples contain visible traces of silicone along the catheters.All catheters were than further investigated using the dino-lite under 60x magnification and found out that 4 of the catheters were affected.The remaining 3 catheters were found to be clean.Based on the investigation conducted, 6 out of 9 samples were found to have silicone filament along the catheter.The correction action will be address through (b)(4) for further analysis.Therefore, this complaint is confirmed, as stated.

Event Description

Reported event: particles, filament or small pieces of silicon were found on several catheters of several lot numbers of size 16.All lot numbers concerned have been quarantined.The patient condition was reported as fine.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5647091
• MDR Text Key: 45151703
• Report Number: 8040412-2016-00070
• 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: 04/14/2016

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: 170605160
• Device Lot Number: 15LE49
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 05/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2016
• 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