BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX PRO-VENT ARTERIAL BLOOD SAMPLING DEVICE

    MDR report key: 3946326 · Received July 9, 2014

    Report

    Report Number
    2183502-2014-00473
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    July 8, 2014
    Manufacturer
    SMITHS MEDICAL, INC.,
    Product Code
    JKA
    PMA / PMN Number
    K952516
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING USE OF THE LISTED DEVICE, A PHLEBOTOMIST WAS SPLASHED IN THE FACE WITH BLOOD. THE BLOOD REPORTEDLY CAME INTO CONTACT WITH THE PHLEBOTOMIST'S MUCOUS MEMBRANES; AFTER WHICH HE REPORTED TO THE EMERGENCY DEPARTEMENT FOR BLOOD BORN PATHOGEN EXPOSURE TESTING AND TREATMENT. NO INFORMATION WAS PROVIDED ON HOW THE EVENT OCCURRED. NO PERMANENT ADVERSE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401814 PORTEX PRO-VENT ARTERIAL BLOOD SAMPLING DEVICE JKA - BLOOD SPECIMEN COLLECTION DEVICE JKA SMITHS MEDICAL, INC., NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention