BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER BRAND NEEDLES

    MDR report key: 2202444 · Received August 5, 2011

    Report

    Report Number
    1024879-2011-00004
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    August 5, 2011
    Product Code
    JKA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT HISTORY CHECK WAS PERFORMED FOR THE LOT NUMBER PROVIDED AND THIS IS THE FIRST COMPLAINT RECORDED. THE CUSTOMER INDICATED THAT SAMPLES WERE AVAILABLE AND WILL BE RETURNED. THESE HAVE NOT BEEN RECEIVED TO DATE. A THOROUGH INVESTIGATION OF THE REPORTED CONDITION HAS BEEN INITIATED AND IS ON-GOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER A VENIPUNCTURE PROCEDURE, THE NEEDLE FAILED TO RETRACT AND WHEN THE PHLEBOTOMIST REMOVED THE NEEDLE FROM THE PATIENT'S ARM, THE PATIENT JERKED CAUSING THE NEEDLE TO PIERCE THE PHLEBOTOMIST'S GLOVE. THE PHLEBOTOMIST WENT TO THE EMERGENCY ROOM AND RECEIVED MEDICATION (LAMIZUDINE AND INDINAVIR SULFATE). BLOOD WORK WAS ALSO DONE AND WILL BE REPEATED AT 3 AND 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD VACUTAINER BRAND NEEDLES PUSH BUTTON BLOOD COLLECTION SET JKA NA 1108040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention