BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9666275 · Received February 4, 2020

    Report

    Report Number
    1024879-2020-00054
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    January 13, 2020
    Report Date
    February 26, 2020
    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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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 MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA#1064141 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD LABEL LIFT OFF/PARTIAL PEEL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BEFORE USE THIS BATCH, THE CUSTOMER FOUND MANY TUBES HAVE LABEL LIFT ISSUE. AFFECT QTY: (B)(4) EA."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD LABEL LIFT OFF/PARTIAL PEEL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BEFORE USE THIS BATCH, THE CUSTOMER FOUND MANY TUBES HAVE LABEL LIFT ISSUE. AFFECT QTY: 3000EA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132079 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 9074743 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other