BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® TRACE ELEMENT SERUM BLOOD COLLECTION TUBES

    MDR report key: 7434048 · Received April 16, 2018

    Report

    Report Number
    1917413-2018-00723
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Date of Event
    October 18, 2016
    Report Date
    April 11, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903683814
    PMA / PMN Number
    K041071
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR 6090562 WITH THE INCIDENT LOT WAS OBSERVED. ROOT CAUSE DESCRIPTION: THE FOLLOWING INFORMATION EXPLAINS THE APPEARANCE OF THE PATTERN WITHIN THE TUBES: THE ADDITIVE FOR THE CAT NO PRODUCT IS APPLIED ONTO THE INTERIOR WALLS OF THE BLOOD COLLECTION VESSEL VIA THE SPRAYCOATING OF A PRESCRIBED AMOUNT OF WATER BASED K2EDTA SOLUTION. THE WATER IS THEN DRIED, LEAVING THE CHARACTERISTIC ¿MIST¿ DOT PATTERN OF RESIDUAL K2EDTA ON THE VESSEL WALL. IN RARE INSTANCES WHERE ASSEMBLY MACHINE MISALIGNMENTS OCCUR, ADDITIVE DISPENSE NOZZLES MAY NOT BE CENTERED WITHIN THE TUBES¿ OPENING AND THE NOZZLES¿ POSITION IS BIASED MORE TOWARDS ONE OF THE VESSEL¿S HEMISPHERES. IN SUCH INSTANCES, ONE SIDE (OR HEMISPHERE) OF THE TUBE VESSEL INTERIOR RECEIVED A HEAVIER COATING OF ADDITIVE SOLUTION, WHILE POINTS ON THE OPPOSING SIDE OF VESSEL RECEIVE A LIGHTER MISTING. LAGER DROPLETS OF THE SOLUTION IN CLOSE PROXIMITY TO ONE ANOTHER THEN TEND TO COALESCE, AND ONCE THE WATER IS DRIED, LEAVE BEHIND A WAFER LIKE DEPOSIT OF THE ADDITIVE. THIS ADDITIVE DEPOSIT VISUALLY STANDS OUT AS IT DOES NOT APPEAR LIKE THE TYPICAL DOT PATTERN FOR THIS TUBE TYPE. INSPECTIONS ARE PERFORMED IN PROCESS AND AT FINAL INSPECT AT A PRESCRIBED RATE AS SPECIFIED IN THE PRODUCT SPECIFICATION. THE VISION INSPECTION ONLINE PERFORMS A CHECK FOR PRESENCE OF ADDITIVE AND IS NOT QUANTITATIVE. THERE HAS BEEN TRAINING THAT HAS BEEN ROLLED OUT TO ALL OPERATORS ALONG WITH A JOB AID FOR UPKEEP OF THE SPRAY COAT THAT WILL HELP WITH THE PREVENTION OF THE DROPLETS. ALONG WITH THE TRAINING THE BED CHAIN WAS CHANGED OUT. THIS WILL HELP IN ASSURING THAT THE TUBES GET PROPERLY ALIGNED WHEN GOING INTO THE SPRAY COAT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® TRACE ELEMENT SERUM BLOOD COLLECTION TUBES HAD FOREIGN MATTER IN TUBE. NO SERIOUS INJURY. NO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277943 BD VACUTAINER® TRACE ELEMENT SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6090562 50382903683814

    Patients

    Seq Age Sex Outcome Treatment
    1 Other