BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX LINE DRAW PLUX W/ DRY LITHIUM HEPARIN AND FILTER-PRO

    MDR report key: 3901002 · Received June 17, 2014

    Report

    Report Number
    2183502-2014-00411
    Event Type
    Injury
    Date Received
    June 17, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SMITHS MEDICAL, INC.
    Product Code
    JKA
    PMA / PMN Number
    K952516
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    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

    USER FACILITY REPORTED THAT FOLLOWING BLOOD SAMPLING, A CLINICIAN AND AN ACCOMPANYING STUDENT OBSERVER WERE EXPOSED TO BLOOD WHILE THE CLINICIAN WAS EXPELLING AIR FROM THE SAMPLE USING THE AIR-FILTER ATTACHMENT. USER FACILITY STATED THAT DURING THIS PROCESS, THE AIR-FILTER ATTACHMENT DISCONNECTED FROM THE SYRINGE AND BLOOD SPRAYED ONTO THE CLINICIAN AND STUDENT OBSERVER. THE CLINICIAN HAD BLOOD SPRAY ONTO HER LEFT EYE, FACE, AND BILATERAL FOREARM. THE STUDENT OBSERVER ALSO WAS SPRAYED ON THE FACE AND ARM. BOTH THE CLINICIAN AND STUDENT OBSERVER REPORTED TO THE EMERGENCY DEPARTMENT IMMEDIATELY FOR BLOOD BORNE PATHOGEN EXPOSURE TESTING AND TREATMENT. NO PERMANENT ADVERSE EFFECTS TO CLINICIAN REPORTED OR STUDENT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356422 PORTEX LINE DRAW PLUX W/ DRY LITHIUM HEPARIN AND FILTER-PRO JKA - BLOOD SPECIMEN COLLECTION DEVICE JKA SMITHS MEDICAL, INC. NA 2642845

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other