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

Catalog Number 318116

Device Problems Deflation Problem (1149); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2014

Event Type  malfunction  

Event Description

Alleged event: the catheters would not deflate.The doctor used a wire to deflate the balloon.The pt's condition was reported as fine.

Manufacturer Narrative

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

• Brand Name: PUREGOLD COUDE 2WPTFE 5CC
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL; perak ; MY
• Manufacturer (Section G): TELEFLEX MEDICAL; p.o. box 28, kamunting; industrial estate, kamunting; perak 3460 0; MY 34600
• Manufacturer Contact: effie jefferson, regulatory aff ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 4426483
• MDR Text Key: 5282053
• Report Number: 8040412-2015-00009
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2014

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: Other
• Device Catalogue Number: 318116
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1