BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAFETY-LOK BLOOD COLLECTION / INFUSION SET

    MDR report key: 3854896 · Received May 28, 2014

    Report

    Report Number
    2243072-2014-00113
    Event Type
    Injury
    Date Received
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BD
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS A LOT NUMBER FOR THIS INCIDENT WAS NOT PROVIDED. CONCLUSIONS: WITHOUT A SAMPLE, A ROOT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED, (B)(4).

    Description of Event or Problem · 1

    THE SAFETY MECHANISM DIDN'T ENGAGE, RESULTING IN A NEEDLESTICK INJURY TO THE NURSE. THE NURSE REQUIRED PROPHYLACTIC TREATMENT AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315062 BD SAFETY-LOK BLOOD COLLECTION / INFUSION SET BLOOD COLLECTION AND INFUSION SET FPA BD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention