MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER

Model Number 129416M

Device Problems Device Damaged Prior to Use (2284); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the temperature sensing foley catheter had bumps running along the outside of the catheter.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation noted bumps on the distal end of the shaft above the thermistor wires.There were 16 bumps in a linear pattern above what appeared to be raised, displaced thermistors.The bumps were present within 8.5 to 13 inches from the proximal end of the catheter.The raised areas measured 20 french and the catheter shaft measured 16.French.The catheter was dissected at the thermistor arm bifurcation and at the shaft where the bumps began in order to observe the internal thermistors.A black and red thermistor was removed from the device.The wires were straightened and measured.The black wire measured 8 inches and the red wire measured 7.9 inches.The portion of formed latex that contained the displaced thermistors measured 6.25 inches.There was an excess of 1.15-1.25 inches of thermistor wiring in the catheter that caused the raised bumps.A potential root cause could be due to "catheter is stretched during insertion".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Only the manufacturing lot number could be found.This catheter is sold in individual packets, trays, and as a product subassembly with various labeling.Based on this a labeling review cannot be completed as the label and revision number sold with this product are unknown.There was not enough information to determine the labeling to be inadequate.Correction: device identification.

Event Description

It was reported that the temperature sensing foley catheter had bumps running along the outside of the catheter.

• Brand Name: BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8268705
• MDR Text Key: 133836650
• Report Number: 1018233-2019-00356
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039775
• UDI-Public: (01)00801741039775
• Combination Product (y/n): N
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2023
• Device Model Number: 129416M
• Device Catalogue Number: 129416M
• Device Lot Number: MCCN2467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1