BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BRAND NEEDLES

    MDR report key: 1904223 · Received November 15, 2010

    Report

    Report Number
    1024879-2010-00015
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 14, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BD
    Product Code
    FMI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED A USED (CONTAMINATED) DEVICE, WHICH WAS VISUALLY INSPECTED AND THE REPORTED CONDITION WAS CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT AFTER A VENIPUNCTURE PROCEDURE, THE RETRACTABLE SAFETY TRIGGER WAS ACTIVATED AND THE METAL NEEDLE REMAINED IN THE PT'S ARM (AS IT BECAME UNATTACHED FROM THE REST OF THE NEEDLE DEVICE). THERE WERE NO REPORTED MEDICAL OR SURGICAL INTERVENTION REQUIRED FOLLOWING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD VACUTAINER BRAND NEEDLES PUSH BUTTON BLOOD COLLECTION SETS FMI BD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other