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

Model Number	119208M
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that temperature-sensing catheter were defective.As per the follow up via email on 11 sep 2020, according to the report, two catheters were used on the patient.No negative impact noted other than multiple unnecessary catheterizations.The exact defect in the catheter was not flushed.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.Visual inspection noted one temperature sensing catheter was received.Visual evaluation noted the thermistor wire was not sitting properly in the thermistor lumen.The drainage lumen was flushed to find that the solution sat in the funnel just above the trifurcation.The catheter was dissected below the trifurcation to find that the thermistor wire had cut through the thermistor wire/drainage lumen wall and was inside the drainage lumen completely blocking the flow of the solution.This fails to meet specifications stating "cuts in lumens are not allowed".Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be tooling misalignment.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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.
Event or Problem Description
It was reported that temperature-sensing catheter were defective.As per the follow up via email on 11sep2020, according to the report, two catheters were used on the patient.No negative impact noted other than multiple unnecessary catheterizations.The exact defect in the catheter was not flushed.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Common Device Name: TEMP SENSING FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10623149
• Report Number: 1018233-2020-06318
• Device Sequence Number: 2880833
• Product Code: EZL
• UDI-Device Identifier: 00801741046261
• UDI-Public: (01)00801741046261
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

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
• Operator of Device: Health Professional
• 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: 09/18/2020
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1