MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH FOLEY CATHETER TIEMANN MODEL COUDE; RED COUDE CATHETER

Model Number	0102L12
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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 the catheter balloon ruptured while deploying into the patient urethra and hence the foley was removed from the urethra.The scheduled procedure for an artificial sphincter was abandoned and the patient was taken to the recovery room.
Additional Manufacturer Narrative
The reported event was confirmed.A photo sample of a red rubber foley catheter was returned.The portion of the shaft was observed to be inflated.The root cause for this failure mode could be due to ¿operator error or machine malfunction.¿ based on the event stated the device was not used and there does appear to be a relationship between the device and the reported event as the catheter photo showed that the shaft was inflated.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not completed as the device was not intended to balloon from the shaft and the user would not likely cause this issue.Corrections: a1, a2, a3, b6, b7, h6.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 the catheter balloon ruptured while deploying into the patient urethra and hence the foley was removed from the urethra.The scheduled procedure for an artificial sphincter was abandoned and the patient was taken to the recovery room.Per additional information received via phone from the facility, the catheter was not used on the patient.The coude catheter was tested for pre-inflation with the sterile water and the catheter ballooned out, like an aneurysm on the shaft of the balloon.The actual catheter balloon did not burst.The patient did not incurred any injury.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER TIEMANN MODEL COUDE
• Common Device Name: RED COUDE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10159432
• Report Number: 1018233-2020-03894
• Device Sequence Number: 2309622
• Product Code: EZC
• UDI-Device Identifier: 00801741018107
• UDI-Public: (01)00801741018107
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: 07/31/2024
• Device Model Number: 0102L12
• Device Catalogue Number: 0102L12
• Device Lot Number: NGENX514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR