BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT

    MDR report key: 2826318 · Received October 31, 2012

    Report

    Report Number
    1119779-2012-00020
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    JTX
    PMA / PMN Number
    K920536A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT CONTAINS AN AMPULE OF REAGENT. THE AMPULE IS CRUSHED AND THE REAGENT IS RELEASED THROUGH A DROPPER INTO A PATIENT SAMPLE. RETURNS WERE UNAVAILABLE FOR ANALYSIS. A REVIEW OF THE COMPLAINT NOTES INDICATES A MISUSE OF THE PRODUCT WHERE THE PROCEDURE, IN THE PRODUCT INSERT, WAS NOT FOLLOWED AT THE POINT OF SPECIMEN COLLECTION. THE PRESENCE OF GLASS IN THE COLLECTION TUBE WOULD INDICATE THAT THE DROPPER TIP WAS REMOVED WHEN DISPENSING THE TRANSFER REAGENT INTO THE COLLECTION TUBE. IF THE PROCEDURE, AS INDICATED IN THE PRODUCT INSERT, WAS FOLLOWED, NO GLASS WOULD'VE BEEN PRESENT IN THE TUBE. A REVIEW OF THE MANUFACTURING PROCESS AND COMPONENTS USED INDICATES THAT NO CHANGES HAVE BEEN MADE WHICH COULD CAUSE THIS DEFECT. A REVIEW OF PAST COMPLAINTS DID NOT REVEAL A CONFIRMED TREND FOR THIS BATCH. ALL CONTENTS IN THE COLLECTION TUBE SHOULD BE TREATED AS PATHOGENICALLY HAZARDOUS MATERIAL, AS INSTRUCTED IN THE PACKAGE INSERT "WARNING: PATHOGENIC MICROORGANISMS, INCLUDING HEPATITIS VIRUSES AND HUMAN IMMUNODEFICIENCY VIRUS, MAY BE PRESENT IN CLINICAL SPECIMENS. "STANDARD PRECAUTIONS" AND INSTITUTIONAL GUIDELINES SHOULD BE FOLLOWED IN HANDLING ALL ITEMS CONTAMINATED WITH BLOOD AND OTHER BODY FLUIDS." THE COMPLAINT IS NOT CONFIRMED FOR ANY PRODUCT DEFECT. BD WILL CONTINUE TO MONITOR THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    A TECHNICIAN WAS PROCESSING A SPECIMEN FOR TESTING ON THE AFFIRM SYSTEM. THE FACILITY RECEIVES SAMPLES FROM MANY DIFFERENT DOCTORS OFFICES. THIS PARTICULAR SAMPLE HAD SHARDS OF GLASS IN IT WHICH THE CUSTOMER THEORIZES CAME FROM THE BROKEN TRANSPORT AMPULE AT THE COLLECTION SITE WITH THE GLASS MAKING ITS WAY INTO THE SAMPLE TUBE. THE TECH AT THE TESTING SITE CUT HER FINGER WHEN SHE WAS SQUEEZING THE TUBE TO DISPENSE THE SAMPLE FOR TESTING. THE CUT CAME FROM A SHARD OF GLASS THAT POKED THROUGH THE PLASTIC TUBE. THE CUT WAS WASHED AND BANDAGED USING BASIC FIRST AID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT JTX BECTON DICKINSON INFUSION THERAPY SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other