BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD WOVEN URETERAL CATHETER

    MDR report key: 11801566 · Received May 10, 2021

    Report

    Report Number
    1018233-2021-02686
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 16, 2021
    Report Date
    June 14, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NNX
    UDI-DI
    00801741071003
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE ¿OPERATOR ERROR¿. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. A LABELING REVIEW IS NOT REQUIRED BECAUSE LABELING COULD NOT HAVE PREVENTED THIS ISSUE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS UNSURE IN REMOVING THE MALE EXTERNAL CATHETER AS THE PATIENT WAS TRYING TO ROLL IT DOWN AS MENTIONED IN THE INSTRUCTIONS BUT IT WOULD NOT COME OFF. THE REPRESENTATIVE DISCUSSED WITH THE PATIENT IF NECESSARY TO APPLY A WARM WET COMPRESS SUCH AS A WET WASHCLOTH AROUND THE CATHETER TO HELP TO LOOSEN THE ADHESIVE. IT WAS ADVISED TO GENTLY ROLL THE CATHETER OFF THE PENIS. THE PATIENT HAS A BOX OF 100 AND USED ABOUT 40 TO 50 AND ALL OF THEM WERE PRESENTED WITH THE SAME ISSUE. ALSO NOTED THAT THEY WERE EXTREMELY DIFFICULT TO GET OFF THE PLASTIC LID OF THE SOMBRERO. THE PATIENT STATED THAT THEY DID NOT JUST POP OFF AS MENTIONED IN THE INSTRUCTIONS. PER FOLLOW UP VIA PHONE ON 07MAY2021, CUSTOMER STATED THAT THE INSTRUCTIONS NEED TO BE MORE CLEAR BECAUSE IT WAS DIFFICULT TO UNDERSTAND HOW TO REMOVE THE CATHETER FROM THE SOMBRERO. AND ALSO STATED THAT THE CATHETER WAS TOO STICKY SO IT WAS DIFFICULT TO REMOVE FROM THE PATIENT AFTER USE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNSURE IN REMOVING THE MALE EXTERNAL CATHETER AS THE PATIENT WAS TRYING TO ROLL IT DOWN AS MENTIONED IN THE INSTRUCTIONS BUT IT WOULD NOT COME OFF. THE REPRESENTATIVE DISCUSSED WITH THE PATIENT IF NECESSARY TO APPLY A WARM WET COMPRESS SUCH AS A WET WASHCLOTH AROUND THE CATHETER TO HELP TO LOOSEN THE ADHESIVE. IT WAS ADVISED TO GENTLY ROLL THE CATHETER OFF THE PENIS. THE PATIENT HAS A BOX OF 100 AND USED ABOUT 40 TO 50 AND ALL OF THEM WERE PRESENTED WITH THE SAME ISSUE. ALSO NOTED THAT THEY WERE EXTREMELY DIFFICULT TO GET OFF THE PLASTIC LID OF THE SOMBRERO. THE PATIENT STATED THAT THEY DID NOT JUST POP OFF AS MENTIONED IN THE INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698794 BARD WOVEN URETERAL CATHETER MALE EXTERNAL CATHETER NNX C.R. BARD, INC. (COVINGTON) -1018233 36104 UNK 00801741071003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other