BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75

    MDR report key: 19240146 · Received May 3, 2024

    Report

    Report Number
    3006260740-2024-02117
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 10, 2024
    Report Date
    April 30, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FPA
    UDI-DI
    00801741047466
    PMA / PMN Number
    K153440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. H3 OTHER TEXT : DEVICE NOT RETURNED FOR EVALUATION

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT, "WE¿VE HAD THREE PRODUCT FAILURES WITH THREE SEPARATE LOT#S, SPECIFIC TO THE BARD 20G X 0.75IN PRIMING PORT INFUSION SETS (REF#0142075.) PATIENT WAS RESTING WHEN RN FLUSHED THE LINE AND NOTED THAT THE TUBING WAS LEAKING DUE TO A CRACK IN THE PORT TUBING ABOVE THE HUB. RN DE-ACCESSED PATIENT DUE TO THE CRACK BUT THE SAFETY DID NOT ENGAGE, LEAVING THE NEEDLE EXPOSED. RN PLACED A CAP AROUND THE END OF THE NEEDLE TO PREVENT INJURY." IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123814 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75 SET, ADMINISTRATION, INTRAVASCULAR FPA C.R. BARD, INC. (BASD) -3006260740 N/A UNK 00801741047466

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other