MAUDE Adverse Event Report: TELEFLEX MEDICAL GOLD 2WAY PED SIL 3CC 8F

Catalog Number 180003080

Device Problem Deflation Problem (1149)

Patient Problem No Information (3190)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample 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 could not be deflated.The device was cut at the level of the water injection site to deflate the balloon.The patient's condition was reported as unknown.

• Brand Name: GOLD 2WAY PED SIL 3CC 8F
• 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: 5314089
• MDR Text Key: 34739904
• Report Number: 8040412-2015-00250
• 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: Physician
• Type of Report: Initial
• Report Date: 12/07/2015

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: 180003080
• Device Lot Number: 14A06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/21/2015
• 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