BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER BRAND NEEDLES

    MDR report key: 2090186 · Received May 6, 2011

    Report

    Report Number
    1024879-2011-00003
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 31, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BD
    Product Code
    JKA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 FOR LOT #0313727. THE CUSTOMER RETURNED ONE (1) SHELF CARTON OF PRODUCT ON (B)(6), FOLLOWED BY AN ADD'L FOURTEEN (14) SHELF CARTONS ON (B)(6). 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 PHLEBOTOMIST COMPLETED A BLOOD DRAW ON A PT WHO WAS CONFIRMED AS BEING (B)(6), THE NEEDLE (CANNULA) RETRACTED WHEN THE BUTTON WAS PRESSED BUT THEN THE DEVICE CAME APART, EXPOSING THE CANNULA AND THIS RESULTED IN A NEEDLE STICK TO THE PHLEBOTOMIST. IT WAS INDICATED THAT THE FACILITY WILL PROVIDE WHATEVER PROPHYLAXIS IS AVAILABLE AND THAT THE HEALTH CARE WORKER IS WILLING TO TAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD VACUTAINER BRAND NEEDLES PUSH BUTTON BLOOD COLLECTION SET JKA BD NA 0313727

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other