BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEO ADULT

    MDR report key: 17366381 · Received July 20, 2023

    Report

    Report Number
    3008258694-2023-00001
    Event Type
    Death
    Date Received
    July 20, 2023
    Date of Event
    June 23, 2023
    Report Date
    July 20, 2023
    Manufacturer
    WAISMED LTD
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    COMPLAINT DESCRIPTION FROM CUSTOMER ON (B)(6), 2023: "TWO OF MY VAT NURSES WE AT THE BEDSIDE FOR A CODE AND DEPLOYED THE DEVICE INTO THE TIBIA OF THE PATIENT. THE NURSE STATED AFTER SQUEEZING THE TRIGGER, THE IO "FELL APART". BOTH NURSE SAID THE TOP HAD SHEARED OFF AND THEY WERE UNABLE TO REMOVE THE TROCHANTER TO USE THE IO. SHE LATER FOUND THE TOP IN THE BED. UNFORTUNATELY, THE PATIENT EXPIRED AND I WAS NOT ABLE TO RETRIEVE THE IO." ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER ON (B)(6), 2023: "CODE IN LABOR DELIVERY, PATIENT WAS POST-PARTUM, INSERTED DEVICE PER INSTRUCTIONS CARD - WHEN DONE SQUEEZED STEP - SMALL METAL ROUND PIECE WAS ON BED, 2 PLASTIC PIECES FELL OFF, NEEDLE WAS FLAT TO TOP - UNABLE TO PULL OUT. CPR HAS BEEN PERFORMED. HOWEVER, NOT AT TIME OF THE NIO-A DEVICE INSERTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616958 NEO ADULT INTRAOSSEOUS ACCESS DEVICE FMI WAISMED LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death