BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP

    MDR report key: 23247885 · Received October 8, 2025

    Report

    Report Number
    1423507-2025-00095
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 18, 2025
    Report Date
    November 6, 2025
    Manufacturer
    CAREFUSION, INC
    Product Code
    LWE
    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 REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001610926 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. PRODUCT UNDERGOES INSPECTIONS DURING MANUFACTURING, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. AWARENESS TRAINING WAS CONDUCTED WITH THE FINISHED GOODS PACKAGING TEAM IN RESPONSE TO THIS INCIDENT. G4: PMA/510(K): K171531; K813338. G3 (DATE RECEIVED BY MANUFACTURER), G6 TYPE OR REPORT - FOLLOW UP# 1), H2 (CORRECTION AND ADDITIONAL INFORMATION), H6: ANNEX G (COMPONENT CODE), ANNEX B (TYPE OF INVESTIGATION), ANNEX C (INVESTIGATION FINDINGS), ANNEX D (INVESTIGATION CONCLUSIONS). 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.

    Additional Manufacturer Narrative · 0

    H11: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE HAS NOT BEEN RETURNED. THE INVESTIGATION IS CURRENTLY UNDERWAY. 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

    IT WAS REPORTED THAT A JAMSHIDI BONE MARROW TRAY CONTAINED A HAIR INSIDE ONE OF THE STERILE BONE MARROW BIOPSY KITS. NO INJURIES OR ADVERSE EVENTS OCCURRED. ONLY ONE KIT WAS AFFECTED, AND NO SAMPLE IS AVAILABLE FOR RETURN AS THE PRACTITIONER DISCARDED THE KIT AND OPENED A NEW ONE BEFORE TAKING A PHOTO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A JAMSHIDI BONE MARROW TRAY CONTAINED A HAIR INSIDE ONE OF THE STERILE BONE MARROW BIOPSY KITS. NO INJURIES OR ADVERSE EVENTS OCCURRED. ONLY ONE KIT WAS AFFECTED, AND NO SAMPLE IS AVAILABLE FOR RETURN AS THE PRACTITIONER DISCARDED THE KIT AND OPENED A NEW ONE BEFORE TAKING A PHOTO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2587111 JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP BONE MARROW COLLECTION/TRANSFUSION KIT LWE CAREFUSION, INC 0001610926 10885403057236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other