BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN

    MDR report key: 8337181 · Received February 13, 2019

    Report

    Report Number
    1917413-2019-00237
    Event Type
    Injury
    Date Received
    February 13, 2019
    Date of Event
    August 27, 2018
    Report Date
    January 29, 2019
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903679602
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: THERE WERE NO SAMPLES AND/OR PHOTOS SUBMITTED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. INVESTIGATION CONCLUSION: THE INVESTIGATION COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE COULD BE DETERMINED AS THE LOT NUMBER IS UNKNOWN. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE LOT NUMBER IS UNKNOWN. RATIONALE: BD LIFE SCIENCES - PREANALYTICAL SYSTEMS HAD NOT RECEIVED ANY SAMPLE AND/OR PHOTOS FROM THE CUSTOMER FACILITY. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN EXPERIENCED POOR BARRIER SEPARATION CAUSING ERRONEOUS RESULTS, RESULTING IN THE PATIENT NEEDING TO RESCHEDULE AN APPOINTMENT AND BE REDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127266 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN NON-EVACUATED BLOOD COLLECTION TUBE IVD JKA BECTON, DICKINSON & CO. UNKNOWN 50382903679602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other