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

Catalog Number 171305-000140

Device Problems Break (1069); Deflation Problem (1149)

Patient Problem No Information (3190)

Event Date 06/19/2015

Event Type  malfunction  

Event Description

Alleged event: the indwelling catheter was cut at the level of the connection.The balloon was deflated and the catheter was removed.The report description does not clearly define if the catheter was broken or if the device was unable to be deflated and had to be cut for removal.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 (14le52) was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Actual sample was returned for investigation.It was observed that the shaft of the sample had detached from its funnel.Further examination on the actual samples using magnifying lens (10xmagnification) did not reveal any sign of abrasion mark or scratch to suggest any manufacturing inadequacy.Based on our experience, it is very unlikely that the catheter could have detached without any external force or external contact.The tube was molded using injection molding machine where tube will be physically mounted in liquid silicone before it gets heated and molded inside the funnel.We did not find any problem within the product, which could have contributed from manufacturing processes.The actual returned sample was tested and complied with required standards.Therefore, we could not confirm this complaint.

Event Description

Alleged event: the indwelling catheter was cut at the level of the connection.The balloon was deflated and the catheter was removed.The report description does not clearly define if the catheter was broken or if the device was unable to be deflated and had to be cut for removal.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: 4929010
• MDR Text Key: 17863213
• Report Number: 8040412-2015-00160
• 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

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 171305-000140
• Device Lot Number: 14LE52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1