BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAMSHIDI

    MDR report key: 7154166 · Received December 29, 2017

    Report

    Report Number
    7154166
    Event Type
    Malfunction
    Date Received
    December 29, 2017
    Date of Event
    November 29, 2017
    Report Date
    December 6, 2017
    Manufacturer
    CAREFUSION 2200, INC
    Product Code
    LWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A BONE MARROW BIOPSY. REPORTEDLY, DURING THE PROCEDURE, WHILE ATTEMPTING TO GET THE ASPIRATE, THE PRACTITIONER REMOVED THE INTRODUCER AND THE HANDLE BROKE OFF. NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933751 JAMSHIDI BONE MARROW COLLECTION/TRANSFUSION KIT LWE CAREFUSION 2200, INC TIN3015

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR NOT KNOWN,| NOT KNOWN.