BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIO ADULT

    MDR report key: 17376206 · Received July 24, 2023

    Report

    Report Number
    9616791-2023-00002
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    June 23, 2023
    Report Date
    July 23, 2023
    Manufacturer
    WAISMED LTD
    Product Code
    FMI
    PMA / PMN Number
    K142086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE WE DID NOT RECEIVE THE LOT NUMBER OF THE DEVICE RELATED TO THIS ADVERSE EVENT, BASED ON SALES HISTORY TO THIS CUSTOMER, WE SUSPECT THAT IT WOULD BE FROM ONE OF THREE LOT NUMBERS AS IDENTIFIED BELOW: LOT 2040021, LOT 2240034 AND LOT 2140024 OUR ENGINEERING TEAM IS IN THE PROCESS OF EVALUATING RETAINED PRODUCT FROM THE SUSPECTED THREE LOTS IDENTIFIED ABOVE. AS SOON AS THEIR EVALUATION IS COMPLETE, WE WILL PROVIDE A FOLLOW-UP REPORT.

    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
    190133 NIO ADULT INTRAOSSEOUS ACCESS DEVICE FMI WAISMED LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Death