MAUDE Adverse Event Report: TELEFLEX MEDICAL TRANSURETHRAL CATHETER; FOLEY CATHETER

Catalog Number 170605-000120

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 06/12/2015

Event Type  malfunction  

Event Description

Alleged event: the head nurse from the rehabilitation unit reported that the catheter was leaking.The measure taken by the nurse was to reinflate the catheter with 8 cc.The patient's condition was reported as unknown.

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.

Manufacturer Narrative

(b)(4).The device history record for lot (13dt29) was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.No alleged defective product or representative sample was returned for investigation purposes.The catheter leak could be due to various reasons.However, in the absence of the complaint sample, further investigation could not be conducted and the actual root cause of this phenomenon could not be determined.Therefore, this complaint could not be confirmed.

Event Description

Alleged event: the head nurse from the rehabilitation unit reported that the catheter was leaking.The measure taken by the nurse was to reinflate the catheter with 8 cc.The patient's condition was reported as unknown.

• Brand Name: TRANSURETHRAL CATHETER
• Type of Device: FOLEY CATHETER
• 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: 4929132
• MDR Text Key: 16955940
• Report Number: 8040412-2015-00155
• 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: Foreign,Health Professional,User Facility,Distributor,distributor,forei
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2015

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: 170605-000120
• Device Lot Number: 13DT29
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1