BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES

    MDR report key: 9218807 · Received October 22, 2019

    Report

    Report Number
    1917413-2019-02233
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Date of Event
    October 7, 2019
    Report Date
    October 8, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679213
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA / 510(K)#: K945952, K901449. 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 LABEL LIFT WITH THE INCIDENT LOT WAS OBSERVED. 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-CONFORMANCE'S DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LABEL ON THE TUBE IS LIFTING WITH A BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES. THIS OCCURRED 120 TUBE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBE LABEL LIFTING. A NEW BATCH OF SHIPMENT FOR THE BD ITEM 367921 SODIUM FLUORIDE POTASSIUM OXALATE TUBE 2ML WAS BEING OBSERVED BY THE QA INSPECTOR OF DISTRIBUTOR DURING THE SECONDARY REPACKAGING ACTIVITY (REDRESSING) DONE IN THEIR WAREHOUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015747 BD VACUTAINER® SODIUM FLUORIDE POTASSIUM OXALATE (FX) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 9095771 50382903679213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other