BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLOC MAX 20G X 0.75 INCH PORT ACCESS NEEDLE

    MDR report key: 11607233 · Received April 2, 2021

    Report

    Report Number
    11607233
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 11, 2021
    Report Date
    March 23, 2021
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ACCESSED WITH A 3/4" INCH 20 GAUGE POWER NEEDLE. FIVE DAYS LATER, THE MOTHER OF THE PATIENT NOTED A CRACK IN THE NEEDLE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504273 POWERLOC MAX 20G X 0.75 INCH PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR FPA BARD ACCESS SYSTEMS, INC. 0142075

    Patients

    Seq Age Sex Outcome Treatment
    1