BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIO ADULT

    MDR report key: 14565969 · Received June 1, 2022

    Report

    Report Number
    9616791-2022-00001
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    March 28, 2022
    Report Date
    May 29, 2022
    Manufacturer
    WAISMED LTD.
    Product Code
    FMI
    UDI-DI
    07290008325059
    PMA / PMN Number
    K142086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WHEN FIRST RECEIVED BY THE MANUFACTURER, REPORTABILITY ASSESSMENT WAS CONDUCTED AND IT WAS DETERMINED THAT IT DIDN'T REQUIRE TO BE REPORTED. WHEN ADDITIONAL INFORMATION WAS RECEIVED ON MAY 3RD 2022, REPORTABILITY ASSESSMENT WAS CONDUCTED AGAIN AND IT WAS DETERMINED THAT THE THIS IS AN EVENT THAT SHOULD BE REPORTED.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER ON (B)(6) 2022: DESCRIBE THE EVENT OR PROBLEM: IO (INTRAOSSEOUS NEEDLE) WAS PLACED TO DELIVER LIFESAVING MEDICATIONS. THERE WAS NO CATHETER WITH THE NEEDLE. THIS CAUSED A DELAY WITH PATIENT GETTING MEDICATIONS. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? TO DELIVER PRESSORS AND RSI MEDICATIONS. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264609 NIO ADULT NEEDLE, HYPODERMIC, SINGLE LUMEN FMI WAISMED LTD. NIO-A 07290008325059

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male