MAUDE Adverse Event Report: TELEFLEX MEDICAL 100% SIL TIEMANN 2WAY 5CC; FOLEY CATHETER

Catalog Number 171305140

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

Alleged event: the balloon burst and the catheter was found in the patient's bed with no balloon so the balloon burst inside the patient's bladder.However the nurse confirmed that the patient evacuated the balloon pieces through natural means.Sterile water 10 cc was used to inflate the balloon.A larger size catheter, size 16, was inserted in the patient.The patient's condition was reported as fine.

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 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.There was no complaint device returned for investigation.Therefore , no physical assessment could be conducted.Burst balloon could be due to various reasons.However, in the absence of returned sample and limited information available on this complaint, further investigation could not be conducted and; therefore complaint is not confirmed.

Event Description

Alleged event: the balloon burst and the catheter was found in the patient's bed with no balloon so the balloon burst inside the patient's bladder.However the nurse confirmed that the patient evacuated the balloon pieces through natural means.Sterile water 10 cc was used to inflate the balloon.A larger size catheter, size 16, was inserted in the patient.The patient's condition was reported as fine.

• Brand Name: 100% SIL TIEMANN 2WAY 5CC
• 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: 4912588
• MDR Text Key: 6013504
• Report Number: 8040412-2015-00147
• 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,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 171305140
• Device Lot Number: 13GE31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1