MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL ALL-SILICONE TEMP SENSING FOLEY CATHETER

Model Number 119208M

Device Problems Inaccurate Flow Rate (1249); Component Misassembled (4004)

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

Event Date 09/22/2020

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 temperature-sensing catheter were defective.

Event Description

It was reported that the temperature-sensing catheter was not flushed.

Manufacturer Narrative

The reported event was confirmed as manufacturing related.1 sample was confirmed to exhibit the reported failure.Visual inspection noted one opened (without original packaging) silicone temperature sensing catheter with molex convector.Visual evaluation noted no obvious visual defects.A potential root cause for this failure could be, "inadequate pressure on the machine to punch." the device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.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.The actual/suspected device was inspected.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10709534
• MDR Text Key: 212260807
• Report Number: 1018233-2020-20255
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046261
• UDI-Public: (01)00801741046261
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• 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: 03/10/2021

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: Lay User/Patient
• Device Expiration Date: 11/21/2023
• Device Model Number: 119208M
• Device Catalogue Number: 119208M
• Device Lot Number: NGCY0380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other