BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7479944 · Received May 2, 2018

    Report

    Report Number
    1917413-2018-01228
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Date of Event
    May 22, 2017
    Report Date
    September 5, 2018
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE DEVICE HISTORY RECORDS WERE REVIEWED FOR BATCH 7033697 WITH NO ISSUES BEING IDENTIFIED. BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE IS THAT AIR BUBBLES IN GEL ARE CAUSED BY AIR POCKETS IN THE GEL MATERIAL OR BY AIR IN THE LINES DURING THE DISPENSE PROCESS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD PAS BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES HAD AIR BUBBLES IN THE GEL.

    Additional Manufacturer Narrative · 1

    BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR 91882 WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES HAD AIR BUBBLES IN THE GEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324522 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 7033697 50382903679602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other