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

Model Number 129416M

Device Problems Inaccurate Flow Rate (1249); Device Sensing Problem (2917); 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 had an unspecified malfunction.Additional information was received via email on 02jan2019, by the complainant that the temperature sensing foley catheter was not draining urine and had bumps running along the catheter.No patient injury was reported.

Manufacturer Narrative

The reported event was unconfirmed.A 30ml slip tip syringe was connected to the catheter at the drainage funnel and water flushed through the drainage lumen while under observation to detect any particulate exiting the device.The drainage lumen passed the water with no resistance or particulate emission.The proximal end of the catheter was then inserted into a hanging bag of water to simulate insertion into a bladder.The water exited through the drainage eyes and drainage funnel as expected.No issues were observed.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.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the temperature sensing foley had an unspecified malfunction.Additional information was received via email on 02jan2019, by the complainant that the temperature sensing foley catheter was not draining urine and had bumps running along the catheter.No patient injury was reported.

• Brand Name: BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: TEMP SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8271518
• MDR Text Key: 134063696
• Report Number: 1018233-2019-00403
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• 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: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1