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

Model Number 129416M

Device Problems Partial Blockage (1065); Inaccurate Flow Rate (1249)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

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 user experienced issues with placement of the catheters on two occasions where they did not work appropriately; both catheters did not drain after placement resulting in replacement.The patient had three affected trays that were used in cvicu and cicu.Per follow up via email on 16feb2021, there were three additional temperature sensing trays affected for a total six from bmcs.

Event Description

It was reported that the user experienced issues with placement of the catheters on two occasions where they did not work appropriately; both catheters did not drain after placement resulting in replacement.The patient had three affected trays that were used in cvicu and cicu.Per follow up via email on 16feb21, there were three additional temperature sensing trays affected for a total six from bmcs.

Manufacturer Narrative

The reported event was confirmed design related.1 sample was confirmed to exhibit the reported failure.As the investigation was confirmed to be design related, the product will not be considered to have failed to meet specification.The reported failure was able to be reproduced.The product was used for treatment purposes.A potential root cause for this failure could be "biological encrustation resulting in blockage.".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required as the reported event is confirmed design related.H11: section a through f - the information provided by bard 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 bard.

• 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 30014
• MDR Report Key: 11387104
• MDR Text Key: 234472842
• Report Number: 1018233-2021-00844
• 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: 10/29/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 129416M
• Device Catalogue Number: 129416M
• Device Lot Number: NGEX3754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 10/30/2021
• Supplement Dates FDA Received: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other