BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE

    MDR report key: 8982670 · Received September 10, 2019

    Report

    Report Number
    1024879-2019-01606
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    August 26, 2019
    Report Date
    October 23, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WITH THE INCIDENT LOT WAS OBSERVED IN THE PHOTOS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA #775841 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND IMPLEMENTED. POOR BARRIER SEPARATION CAN BE CAUSED BY MANY SOURCES, INCLUDING CERTAIN PATIENT PATHOLOGICAL CONDITIONS, IMPROPER SPECIMEN COLLECTION, SPECIMEN PROCESSING, AND SPECIMEN TRANSPORT. SPECIMEN COLLECTION FACTORS THAT CAN CONTRIBUTE TO POOR BARRIER SEPARATION RANGE FROM PROLONGED TOURNIQUET TIME AND IMPROPER VENIPUNCTURE TECHNIQUE TO TRANSFERRING A SAMPLE FROM A SYRINGE DRAW OR IV CATHETER. SPECIMEN PROCESSING FACTORS INCLUDE VIGOROUS MIXING OR SHAKING OF THE SPECIMEN, NOT ALLOWING THE SPECIMEN TO CLOT FOR THE RECOMMENDED AMOUNT OF TIME, PROLONGED CONTACT OF SERUM OR PLASMA WITH CELLS, AND EXPOSURE TO EXCESSIVE HEAT OR COLD. FINALLY, MECHANICAL TRAUMA AND OTHER ADVERSE CONDITIONS DURING TRANSPORT OF TUBES CAN RESULT IN POOR BARRIER SEPARATION.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING POOR SEPARATOR MOVEMENT DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE GEL LAYER FAILED TO FORM. CUSTOMER TEXT: # (B)(6). GEL LAYER FAILED TO FORM1 TUBE LOT 8092619, EXP 8-31-19.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING POOR SEPARATOR MOVEMENT DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE GEL LAYER FAILED TO FORM. CUSTOMER TEXT: (B)(6). GEL LAYER FAILED TO FORM1 TUBE LOT 8092619 ,EXP 8-31-19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778315 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9143649 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other