BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP

    MDR report key: 24580073 · Received March 12, 2026

    Report

    Report Number
    1423507-2026-00041
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 2, 2026
    Manufacturer
    CAREFUSION, INC
    Product Code
    KNW
    UDI-DI
    10885403057236
    PMA / PMN Number
    SEE H.11.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11. NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. THE COMPLAINT HAS BEEN LOGGED IN THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE MONITORED THROUGH TRACKING, TRENDING, AND QUALITY DATA ANALYSIS FOR POTENTIAL FUTURE OCCURRENCES. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN B3 (DATE OF EVENT: DATE OF AWARENESS WAS ENTERED IN THE DATE OF EVENT FIELD AS THE ACTUAL DATE OF EVENT IS UNKNOWN). G4: PMA/510K : K171531;K813338. D2: PROCODE: FSH;KNW. SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT CERTAIN COMPONENTS WITHIN THE JAMSHIDI BONE MARROW TRAY 11G X 4, 15G ASP WERE FOUND TO BE DUSTY OR DIRTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222873 JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP INSTRUMENT, BIOPSY KNW CAREFUSION, INC UNKNOWN 10885403057236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown