MAUDE Adverse Event Report: TELEFLEX MEDICAL PUREGOLD COUDE 2WPTFE 5CC; CATHETER

Catalog Number 318116

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

Complaint alleges that complainant attempted to withdraw water from the balloon to check patency per the doctor's recommendation, during the term of wear.The catheter was cut at the lumen juncture and removed.No pt injury reported.Current pt condition reported as fine.

Manufacturer Narrative

(b)(4).The device sample was not received by the manufacturer at the time of this report.

• Brand Name: PUREGOLD COUDE 2WPTFE 5CC
• Type of Device: CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia ; MY
• Manufacturer (Section G): TELEFLEX MEDICAL; p.o. box 28, kamunting industrial estate; perak, west malaysia 3460 0; MY 34600
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4507679
• MDR Text Key: 21450318
• Report Number: 8040412-2015-00033
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 318116
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1