BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3002769706-2017-00258

    MDR report key: 6831095 · Received August 30, 2017

    Report

    Report Number
    3002769706-2017-00258
    Event Type
    Malfunction
    Date Received
    August 30, 2017
    Report Date
    November 20, 2017
    PMA / PMN Number
    K933939
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHLEBOTOMIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE INCOMING QUALITY RELEASE A INSPECTION RECORDS FOR THE BACT/ALERT® BLOOD COLLECTION ADAPTER CAP, LOT 10099, WERE REVIEWED AND MET ALL RELEASE CRITERIA. THE INVESTIGATION TEAM TRIED TO RECREATE THE EVENTS USING RETENTION SAMPLES OF THE SAME BTA LOTS OF PRODUCTS AND ACCESSORIES USED BY THE CUSTOMER. THE TEAM WAS ABLE TO LOCK THE BTA ADAPTER INSERTS IN THE BTA ADAPTER CAPS BY TWISTING THE BTA ADAPTER INSERT AND ALIGNING THE RIDGES INSIDE THE ADAPTER CAP WITH THE FLANGES ON THE ADAPTER INSERT. WHEN APPROPRIATELY ALIGNED, THE TWO FIT SNUGLY TOGETHER AND CANNOT ROTATE FREELY. THE TEAM DID FIND THAT THE BTA ADAPTER INSERT WOULD COME OUT OF THE BTA ADAPTER CAP WHEN CHANGING OUT THE BD VACUTAINER TUBES IF THE ADAPTER INSERT WAS NOT LOCKED INTO PLACE OR IF THE VACUTAINER TUBE WAS PULLED OUT AT AN ANGLE. HOWEVER, IF AN ADAPTER INSERT WAS REMOVED, IT COULD EASILY BE PUT BACK IN THE BTA ADAPTER CAP WITHOUT TOUCHING THE NEEDLE. CUSTOMERS ARE REMINDED TO FOLLOW THE ADAPTER CAP INSTRUCTIONS FOR USE. THE IFU ADEQUATELY AND PROPERLY INSTRUCTS THE CUSTOMER TO HANDLE BIOLOGIC SAMPLES AND BLOOD COLLECTION "SHARPS" IN ACCORDANCE WITH THE POLICIES AND PROCEDURES OF THEIR FACILITY. THE IFU INSTRUCTS THE USER NOT TO REMOVE THE INSERT FROM THE CAP AFTER COLLECTION AND TO DISCARD THE BTA BLOOD COLLECTION ADAPTER CAP AND INSERT AFTER SINGLE USE. THE IFU IS CLEAR IN INSTRUCTING THE CUSTOMER TO COLLECT THE BLOOD IN THE BTA BLOOD CULTURE BOTTLES FIRST, BEFORE PLACING THE ADAPTER INSERT INTO THE ADAPTER CAP TO DRAW THE BLOOD INTO THE VACUUM COLLECTION TUBES. ALSO, THE IFU INSTRUCTS THE CUSTOMER TO FOLLOW THE MANUFACTURER'S INSTRUCTIONS FOR THE HANDLING OF VACUUM COLLECTION TUBES. THE ROOT CAUSE OF THE ISSUE IS HUMAN ERROR.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF AN OCCURRENCE WHERE A PHLEBOTOMIST CUT THEIR FINGER WHILE USING THE BACT/ALERT® ADAPTER CAP. THE CUSTOMER REPORTED THAT THE INSERT WAS NOT PROPERLY SEATED, THE ADAPTOR GOT STUCK AND AS THE PHLEBOTOMIST ATTEMPTED TO PULL IT OUT, A FINGER GOT SNAGGED. THE PHLEBOTOMIST HAD DIFFICULTY AND ENDED UP GETTING STUCK WITH THE PART OF THE NEEDLE THAT GOES INTO THE DRAWING TUBE. THE CUSTOMER REPORTED BELIEVING THE ISSUE WAS RELATED TO THE ADAPTORS AND THE INSERTS. THE PHLEBOTOMIST HAD THEIR BLOOD DRAWN FOR HIV AND HEPATITIS TESTING AND WILL ONLY RECEIVE TREATMENT IF THE TEST COMES BACK POSITIVE. NO BASIC FIRST AID TREATMENT WAS ADMINISTERED. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Patients

    Seq Age Sex Outcome Treatment
    1