BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ECLIPSE BLOOD COLLECTION NEEDLE 21GX1.25"

    MDR report key: 4452594 · Received January 20, 2015

    Report

    Report Number
    2243072-2015-00008
    Event Type
    Injury
    Date Received
    January 20, 2015
    Date of Event
    January 9, 2014
    Report Date
    January 23, 2014
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORDS QUALITY NOTIFICATIONS REVEALED NO IRREGULARITIES DURING THE MFR OF REPORTED LOT NUMBER 4142848. CONCLUSIONS: WITHOUT A SAMPLE, A ROOT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A 21 GAUGE BD ECLIPSE BLOOD COLLECTION NEEDLE, THE SAFETY GUARD BROKE OFF AFTER DISENGAGING THE DEVICE FROM THE PT'S ARM AND THE CLINICIAN OBTAINED A NEEDLE STICK INJURY. THE CLINICIAN WAS EVALUATED AT A HOSPITAL AND RECEIVED PROPHYLACTIC MEDICATION POST EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44422 BD ECLIPSE BLOOD COLLECTION NEEDLE 21GX1.25" BLOOD COLLECTION NEEDLE FMI BECTON DICKINSON 4142848

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention