BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIO- ADULT

    MDR report key: 7917513 · Received September 28, 2018

    Report

    Report Number
    9616791-2018-00001
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    July 7, 2018
    Report Date
    November 8, 2018
    Manufacturer
    WAISMED LTD.
    Product Code
    FMI
    UDI-DI
    07290008325059
    PMA / PMN Number
    K142086
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE COMPLAINANT EVENT DESCRIPTION, AND THE FACT THAT BONE MARROW WAS DRAWN, WAISMED CAN ASSUME THAT THE NEEDLE WAS PLACED IN THE MARROW CAVITY FOLLOWING PROPERLY DEVICE ACTIVATION. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. DEVICES FROM THE SAME LOT NUMBER FROM THE ARCHIVE WERE USED FOR EVALUATION. THE INVESTIGATION IS ONGOING. WAISMED WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS. BECAUSE FIELD IN THIS REPORT IS MANDATORY, MALFUNCTION WAS MARKED, BUT BASED ON THE ABOVE, THE MALFUNCTION WAS NOT ESTABLISHED, AND WAISMDE ASSUMPTION IS THAT THE DEVICE WAS ACTIVATED PROPERLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NIO DEPLOYED IN THE LEFT TIBIA OF THE PATIENT. AFTER FLUSHING, IT WAS REPORTED THAT BONE MARROW WAS PRESENT AND NEEDLE PLACEMENT IN THE MARROW CAVITY WAS CONFIRMED. SEVERAL MINUTES AFTER DEPLOYMENT, PATIENT'S LEG APPEARED SWOLLEN IN COMPARISON TO HIS RIGHT LEG. THE PATIENT BECAME RESPONSIVE TO TREATMENTS AFTER ACCESS VIA DIFFERENT IO NEEDLE WAS PLACED.

    Additional Manufacturer Narrative · 1

    BASED ON THE COMPLAINANT EVENT DESCRIPTION, AND THE FACT THAT BONE MARROW WAS DRAWN, WAISMED CAN ASSUME THAT THE NEEDLE WAS PLACED IN THE MARROW CAVITY FOLLOWING PROPERLY DEVICE ACTIVATION. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. DEVICES FROM THE SAME LOT NUMBER FROM THE ARCHIVE WERE USED FOR EVALUATION. THE INVESTIGATION IS ONGOING. WAISMED WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS. BECAUSE FIELD IN THIS REPORT IS MANDATORY, MALFUNCTION WAS MARKED, BUT BASED ON THE ABOVE, THE MALFUNCTION WAS NOT ESTABLISHED, AND WAISMED ASSUMPTION IS THAT THE DEVICE WAS ACTIVATED PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NIO DEPLOYED IN THE LEFT TIBIA OF THE PATIENT. AFTER FLUSHING, IT WAS REPORTED THAT BONE MARROW WAS PRESENT AND NEEDLE PLACEMENT IN THE MARROW CAVITY WAS CONFIRMED. SEVERAL MINUTES AFTER DEPLOYMENT, PATIENT'S LEG APPEARED SWOLLEN IN COMPARISON TO HIS RIGHT LEG. THE PATIENT BECAME RESPONSIVE TO TREATMENTS AFTER ACCESS VIA DIFFERENT IO NEEDLE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758131 NIO- ADULT NIO-ADULT FMI WAISMED LTD. NIO-A 1730055 07290008325059

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR