MAUDE Adverse Event Report: TELEFLEX MEDICAL GOLD 2WAY SIL 5CC 14FR; FOLEY CATHETER

Catalog Number 180705140

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

Alleged event: the balloon failed to deflate when it was time to remove the catheter; cutting the shaft failed to work as well.The patient was repositioned and the catheter was manipulated until another staff member was able to aspirate enough water that the catheter was able to be removed.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 141139 provided is not present in system, therefore a dhr review could not be conducted.There was no sample returned for investigation.Therefore; investigation was conducted based on current production samples.Catheters passed the requirements of the functionality test.Visual inspection conducted on the samples observed there was no burst or crack found on the balloons.Based on investigation conducted, production samples are fully functional.The balloons were able to inflate and deflate without any difficulties faced.Furthermore, the catheters have passed the soak test, which indicates no leak of water during catheterization.Then, the catheters also have passed reverse flow rate test, which indicates no blockage of the drainage lumen.No other abnormalities were observed.Therefore, this complaint could not be confirmed.

Event Description

Alleged event: the balloon failed to deflate when it was time to remove the catheter; cutting the shaft failed to work as well.The patient was repositioned and the catheter was manipulated until another staff member was able to aspirate enough water that the catheter was able to be removed.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The device lot number that was provided by the customer is unknown; therefore, a dhr review could not be conducted.One actual complaint sample was returned for investigation.Visual examination was conducted and the catheter was unable to expand, because the balloon area was flattened, as it had been pressed with heavy object or due to excessive aspiration during catheter removal and manipulation.Reviewing the manufacturing process, no potential cause could have contributed to the problem.All products were subjected to 100% inspection of leak test, inflation, and deflation test.The defect related to functionality of the product will be culled out during inspection.Based on analysis conducted, the returned catheter could not inflate due to the balloon area indentation.Since there was no blockage issue observed based on reported failure, therefore; this complaint could not be confirmed.

Event Description

Alleged event: the balloon failed to deflate when it was time to remove the catheter; cutting the shaft failed to work as well.The patient was repositioned and the catheter was manipulated until another staff member was able to aspirate enough water that the catheter was able to be removed.The patient's condition was reported as fine.

• Brand Name: GOLD 2WAY SIL 5CC 14FR
• 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: 4973619
• MDR Text Key: 16955039
• Report Number: 8040412-2015-00168
• Device Sequence Number: 1
• Product Code: FGH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 07/13/2015

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: 180705140
• Device Lot Number: 14I139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2015
• Initial Date FDA Received: 08/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1