BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLOC MAX PORT ACCESS KIT 20G X 0.75IN

    MDR report key: 16588088 · Received March 21, 2023

    Report

    Report Number
    3006260740-2023-00925
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    March 1, 2023
    Report Date
    March 15, 2023
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FPA
    UDI-DI
    00801741044298
    PMA / PMN Number
    K171735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE TRANSITIONED FROM A CUSTOM KIT TO THE STANDARD KIT (2142075). DURING THAT TIME (1 MONTH) THEY HAVE HAD SEVERAL PAIRS OF GLOVES THAT BREAK APART EASILY. NO OTHER INFORMATION WAS PROVIDED. THE CUSTOMER DID NOT GIVE A SPECIFIC QUANTITY OF AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754523 POWERLOC MAX PORT ACCESS KIT 20G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR FPA C.R. BARD, INC. (BASD) -3006260740 N/A REGZ1717 00801741044298

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other