MAUDE Adverse Event Report: TELEFLEX MEDICAL GOLD 2WAY SIL 5CC 18FR; FOLEY CATHETER

Catalog Number 180705180

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

Alleged event: the balloon would not deflate at time of the change.A physician had to puncture the balloon for removal.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#: (b)(4).The device sample has not been returned to the mfr for investigation at the time of this report.The mfr will continue to monitor and trend related events.

Manufacturer Narrative

(b)(4).The device history record was reviewed based on the lot and catalog number of the received representative samples and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specifications.Visual examination of the samples received did not reveal any obvious defect or abnormality.The balloons were able to be inflated without any difficulty.No foreign particles, no collapse of the lumen, or leaks occurred during functional and time lapse testing.Based on the analysis conducted, all of the returned samples are fully functional.The complaint could not be confirmed as no product dysfunction issue was detected.The manufacturer will continue to monitor and trend related events.

• Brand Name: GOLD 2WAY SIL 5CC 18FR
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia ; MY
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; industrial estate, kamunting; perak, west malaysia 3460 0; MY 34600
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 4801671
• MDR Text Key: 21092517
• Report Number: 8040412-2015-00101
• Device Sequence Number: 1
• Product Code: FGH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2015

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: 180705180
• Other Device ID Number: 20013119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 05/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention