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

Catalog Number 170605-000140

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

Alleged event: the nurse inserted the catheter, when balloon was inflated, it snapped.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#(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.The returned sample was 100% visually inspected using magnification lens.The sample appeared to be in a good condition except that the balloon was split.Closer examination on the split balloon area under dino-lite revealed scratch marks near the tear region.Any defective raw balloon will be culled out before being sent to the next process.After assembly, all foley catheters are then subjected to leak test.Products that pass this test will be subjected to the next process.Based on the investigation and testing conducted on the actual sample, the split balloon could had been due to contact with sharp object such as encrustation or bladder stone that weaken the balloon membrane.Therefore, we could not confirm this complaint, as stated.

Event Description

Alleged event: the nurse inserted the catheter, when balloon was inflated, it snapped.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: 4929667
• MDR Text Key: 6436003
• Report Number: 8040412-2015-00163
• 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,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2015

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: 170605-000140
• Device Lot Number: 14LE451
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1