BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    MDR report key: 9401198 · Received December 3, 2019

    Report

    Report Number
    1917413-2019-02454
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 18, 2019
    Report Date
    January 16, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679602
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. 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. HEMOLYSIS 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 HEMOLYSIS 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 HEMOLYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES WERE USED AND THE CUSTOMER EXPERIENCED HEMOLYSIS. THIS OCCURRED ON 6 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367960, BATCH NO. 9220492 - IT IS REPORTED CUSTOMER EXPERIENCED INCREASED HEMOLYSIS USING VACUTAINERS. I AM WONDERING IF THERE HAVE BEEN ANY RECENT CLAIMS OF INCREASED HEMOLYSIS IN THE 3ML LITHIUM HEPARIN PST TUBES? MY FACILITY HAS SEEN A SLIGHT INCREASE.

    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 WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES WERE USED AND THE CUSTOMER EXPERIENCED HEMOLYSIS. THIS OCCURRED ON 6 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367960, BATCH NO. 9220492. IT IS REPORTED CUSTOMER EXPERIENCED INCREASED HEMOLYSIS USING VACUTAINERS. I AM WONDERING IF THERE HAVE BEEN ANY RECENT CLAIMS OF INCREASED HEMOLYSIS IN THE 3ML LITHIUM HEPARIN PST TUBES? MY FACILITY HAS SEEN A SLIGHT INCREASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201933 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367960 9220492 50382903679602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other