BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIO-I

    MDR report key: 18371583 · Received December 21, 2023

    Report

    Report Number
    9616791-2023-00005
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    October 27, 2023
    Report Date
    December 21, 2023
    Manufacturer
    WAISMED LTD
    Product Code
    FMI
    UDI-DI
    07290008325066
    PMA / PMN Number
    K190538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TEXT COPIED FROM INFORMATION RECEIVED FROM CUSTOMER QUESTIONNAIRE IN HANDWRITING ON 01 NOVEMBER 2023: "SAVED TO CODE CRITICAL IN ED, IN RESPIRATORY DISTRESS DUE TO OVERDOSE OF SEIZURE MEDICATION FROM THE NEW ADOPTING PARENT, MULTIPLE ATTEMPTS FROM PIV"S WERE UNSUCCESSFUL. ED MD AND VAT BOTH TRIED NIO INFANT IO'S BOTH WERE ABLE TO GET BLOOD RETURN BUT WERE NOT ABLE TO FLUSH BOTH. SINCE THIS INSERT GOES BILATERALLY ONLY WITH DOWNWARD PRESSURE ON A LYE OLD, WE FELT THIS PRODUCT COULD POTENTIALLY HYPER EXTEND OR BREAK THE LEG OF THE CHILD BEFORE PUNCTURING THE BONE DID NOT FLUSH WHEN PRODUCT WAS BILATERALLY. FINALLY CORRECTLY INSERTED IT." ON (B)(6) A TELEPHONE CONFERENCE WAS HAD WITH SUSO AND THE CUSTOMER. AT THAT TIME THE CUSTOMER DISCLOSED THAT THE PATIENT EXPIRED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305441 NIO-I NIO INFANT INTRAOSSEOUS ACCESS DEVICE FMI WAISMED LTD 07290008325066

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Female Death