BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIO ADULT

    MDR report key: 20648712 · Received November 10, 2024

    Report

    Report Number
    9616791-2024-00002
    Event Type
    Malfunction
    Date Received
    November 10, 2024
    Report Date
    October 11, 2024
    Manufacturer
    WAISMED LTD
    Product Code
    FMI
    UDI-DI
    07290008325059
    PMA / PMN Number
    K142086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS BEEN CONTACTED SEVERAL TIMES IN AN ATTEMPT TO OBTAIN ADDITIONAL DETAILS CONCERNING THE DEVICE INVOLVED IN THE REPORTED EVENT. UNFORTUNATELY, WE HAVE NOT RECEIVED ANY CLARIFICATION OR FURTHER INFORMATION REGARDING THE EVENT OR RETURNING OF THE DEVICE ITSELF. WE WILL CONTINUE TRYING TO GET EXTRA DETAILS AND A FOLLOW UP REPORT WILL BE DONE IN CASE OF NEW INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    COMPLAINT DESCRPTION FROM CUSTOMER ON OCTOBER 15, 2024: "WE RECENTLY HAD AN NIO ADULT DEVICE MALFUNCTION DURING A CODE EVENT. WE STOCK THESE IN OUR CODE CARTS AND WHEN MY TEAM MEMBER ATTEMPTED TO INSERT THE DEVICE, FOLLOWING THE IFU, IT DEPLOYED, WITH DELAY, AND ACTUALLY FELL APART. FOLLOWS IS THE COMMUNICATION I RECEIVED FROM MY COLLEAGUE: I WENT TO PLACE AN NIO DURING A CODE AND IT WAS VERY DIFFICULT TO DEPLOY THE NIO. I AM COMFORTABLE PLACING THE NIO AND USING THE NIO DEVICE. THE DEVICE I USED WAS FROM THE CRASH CART AND THERE ARE NO EXTRAS IN THE CRASH CART WHEN SOMETHING LIKE THIS OCCURS. HERE WAS THE SEQUENCE: I HAD UNLOCKED IT, UNCAPPED IT, WAS STABILIZING IT AND DID THE SQUEEZE AND FINALLY, AFTER WHAT SEEMED LIKE AN ETERNITY IN A BAD SITUATION, IT DID DEPLOY BUT AT THE SAME TIME, THE ENTIRE NIO APPARATUS EXPLODED. LITERALLY. I DON'T KNOW WHAT TO SAY. I DID SAVE IT FOR YOU IF YOU WANT TO TAKE A LOOK, BUT THAT IS SERIOUSLY WHAT HAPPENED. I CAME BACK TO THE OFFICE AFTER I WAS ORGANIZED AND GRABBED ANOTHER NIO JUST TO SEE IF IT WAS ME AND NOPE. IT DEPLOYED EASY JUST LIKE IT SHOULD. NO ISSUES AND NO EXPLOSION. NO HARM WAS DONE TO THE PATIENT OTHER THAN A DELAY IN VASCULAR ACCESS. I HAVE THE ACTUAL DEVICE, IN PIECES, IN A BAG TO SEND FOR INSPECTION. I WOULD LIKE TO REPORT THIS FOR THE RECORD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317454 NIO ADULT INTRAOSSEOUS ACCESS DEVICE FOR ADULTS FMI WAISMED LTD NIO-A 2340036 07290008325059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown