BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE

    MDR report key: 2071872 · Received April 21, 2011

    Report

    Report Number
    MW5020385
    Event Type
    Injury
    Date Received
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    COVIDIEN SURGICAL SUPPLY
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BONE MARROW BIOPSY TRAYS EITHER KENDALL OR CARDINAL SUPPLIED BY (B)(4), CONTAIN 16GA ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE/LENGTH -3/16" X 1-7/8". OVER THE PAST 4 MONTHS, THERE HAVE BEEN 12 INSTANCES WHERE THE NEEDLES WERE NOTED TO BE BENT AFTER INSERTION INTO PATIENT'S ILIAC REGION TO ACCRUE BONE MARROW ASPIRATES. PROD. REF # (B)(4) LOT# PO123014 EXP DATE: (B)(6) 2011. THE (B)(4) COMPANY'S QUALITY ASSURANCE DEPARTMENT HAS BEEN CONTACTED AND THEY REQUESTED A SAMPLE OF ONE OF THE BENT NEEDLES IN ORDER TO DO A QUALITY CONTROL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE GAA COVIDIEN SURGICAL SUPPLY PO123014

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability