BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED BD BONE MARROW ASPIRATION NEEDLE

    MDR report key: 6433264 · Received March 24, 2017

    Report

    Report Number
    2243072-2017-00023
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    March 1, 2017
    Report Date
    June 12, 2017
    Manufacturer
    BECTON DICKINSON
    Product Code
    FCG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THIS COMPLAINT IS A DUPLICATE OF BD CAREFUSION COMPLAINT (B)(4). AN MDR WAS SUBMITTED ON 3/28/2017 UNDER REPORT # 1625685-2017-00278.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD BONE MARROW ASPIRATION NEEDLE BROKE OFF IN A PATIENT'S POSTERIOR ILIAC CREST. SURGERY WAS CONSULTED AND THE PATIENT HAD TO GO TO THE OR TO HAVE THE BROKEN NEEDLE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216237 UNSPECIFIED BD BONE MARROW ASPIRATION NEEDLE BIOPSY BONE MARROW NEEDLE FCG BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention