BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE MARROW ASPIRATION NEEDLE SET

    MDR report key: 26372 · Received July 31, 1995

    Report

    Report Number
    26372
    Event Type
    Injury
    Date Received
    July 31, 1995
    Date of Event
    March 7, 1995
    Report Date
    March 13, 1995
    Manufacturer
    POPPER & SONS, INC.
    Product Code
    LWE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING BONE MARROW ASPIRATION OF THE LEFT ILIAC CREST, APPROX 2 INCH DISTAL PORTION OF NEEDLE BROKE OFF AT HUB OF SHEATH. BROKEN PORTION REMAINED IN SUBCUTANEOUS TISSUE OF THE PT. PT IN NO DISTRESS-STABLE CONDITION SURGERY CONSULT NEEDED TO REMOVE DEVICE. NEEDLE REMOVED IN RADIOLOGY SPECIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE MARROW ASPIRATION NEEDLE SET NEEDLE SET LWE POPPER & SONS, INC. NEEDLE 406

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention