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

Catalog Number 170605

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2015

Event Type  malfunction  

Event Description

Alleged event: the funnel was torn after a few days.Catheter was replaced.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 lot number was not provided; therefore a device history record (dhr) review could not be conducted.Under visual examination, no design abnormality or material degradation were observed on the catheter.However a tear was observed at drainage funnel.Based on additional information, the failure occurred after 3 days of usage.This indicated that the product was able to perform well at the beginning.There are various reasons which could have likely contributed towards torn or broken, funnel.In current standard operating procedure, 100% visual inspection is conducted on the catheter and product is released upon passing this inspection.Based on the investigation conducted, there are various reasons that could cause the funnel to be torn and in current manufacturing process 100% visual inspection is conducted whereby defective product will be culled out.Therefore we are not able to confirm this complaint.

Event Description

Alleged event: the funnel was torn after a few days.Catheter was replaced.The patient's condition was reported as fine.

• 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: 4929266
• MDR Text Key: 6435553
• Report Number: 8040412-2015-00153
• Device Sequence Number: 1
• Product Code: FGH
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2015
• 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