BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREWICK ACCESSORIES REPLACEMENT KIT

    MDR report key: 12083967 · Received June 29, 2021

    Report

    Report Number
    1018233-2021-03876
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    June 5, 2021
    Report Date
    October 8, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741185380
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION RECEIVED, IT HAS BEEN DETERMINED THAT THIS MDR EVENT IS NOT REPORTABLE. 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 MIGHT HAVE URINARY TRACT INFECTION AND THE PUREWICK ACCESSORY TUBING WAS VERY DIRTY AND THAT MIGHT BE THE CAUSE. IT WAS NOTED THAT THE PATIENT HAD NOT SEEN A DOCTOR NOR BEEN DIAGNOSED WITH URINARY TRACT INFECTION. ALSO NOTED THAT THE ACCESSORY KIT WAS DELIVERED AS PART OF THE PW200 ON (B)(6) 2021, ALMOST FOUR MONTHS AGO. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION. FOLLOW-UP CALL PERFORMED ON (B)(6) 2021. PATIENT WAS HAVING URINARY TRACT INFECTION BEFORE STARTED USING THE PUREWICK. ALSO STATED THAT THE TUBING HAD BEEN IN USE FOR MORE THAN 60 DAYS BECAUSE MEDICARE WOULD NOT PAY FOR NEW KITS AND PATIENT HAD TO PAY OUT OF POCKET. PATIENT WAS CURRENTLY BEING TREATED FOR URINARY TRACT INFECTION SO THE PUREWICK WAS NOT BEING USED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MIGHT HAVE A URINARY TRACT INFECTION AND THE PUREWICK ACCESSORY TUBING WAS VERY DIRTY AND THAT MIGHT BE THE CAUSE. IT WAS NOTED THAT THE PATIENT HAD NOT SEEN A DOCTOR NOR BEEN DIAGNOSED WITH URINARY TRACT INFECTION. ALSO NOTED THAT THE ACCESSORY KIT WAS DELIVERED AS PART OF THE PW200 ON (B)(6) 2021, ALMOST FOUR MONTHS AGO. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980262 PUREWICK ACCESSORIES REPLACEMENT KIT PUREWICK ACCESSORIES REPLACEMENT KIT NZU C.R. BARD, INC. (COVINGTON) -1018233 PWKIT03 UNK 00801741185380

    Patients

    Seq Age Sex Outcome Treatment
    1 Other