BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIO ADULT

    MDR report key: 17955292 · Received October 18, 2023

    Report

    Report Number
    9616791-2023-00004
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    September 8, 2023
    Report Date
    October 15, 2023
    Manufacturer
    WAISMED LTD
    Product Code
    FMI
    UDI-DI
    07290008325059
    PMA / PMN Number
    K142086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    COMPLAINT DESCRIPTION FROM CUSTOMER ON (B)(6) 2023. "VAT NURSE OPENED PACKAGE, UNLOCKED DEVICE BY TWISTING TOP, SQUEEZED DOWN AND THE NEEDLE DID NOT DEPLOY. SECOND NURSE STEPPED IN AND ATTEMPTED TO DEPLOY NEEDLE AND GOT A NEGATIVE RESPONSE. THEY OPENED ANOTHER UNIT, FOLLOWED THE SAME STEPS, AND SUCCESSFULLY DEPLOYED NEEDLE INTO PATIENT. THERE WAS A ONE-TO-TWO-MINUTE DELAY BETWEEN START AND DEPLOYMENT BECAUSE OF THIS INCIDENT. BOTH NURSES HAVE BEEN TRAINED ON THE DEVICE AND HAVE SUCCESSFULLY USED IT IN THE PAST".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241862 NIO ADULT INTRAOSSEOUS ACCESS DEVICE FMI WAISMED LTD NIO A 2040021 07290008325059

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown