BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 9534128 · Received December 31, 2019

    Report

    Report Number
    1024879-2019-02187
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 12, 2019
    Report Date
    January 8, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678155
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: EVEN THOUGH PHOTOS WERE ATTACHED THEY DO NOT BELONG TO LOT 9210554. THIS IS A KNOWN ISSUE, THEREFORE BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA#1064141. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THE LABELS WERE LIFTING OFF. THERE WERE 40000 TUBES REPORTED TO HAVE THIS CONDITION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, LABEL FLOATING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THAT BEFORE USE OF THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THE LABELS WERE LIFTING OFF. THERE WERE 40000 TUBES REPORTED TO HAVE THIS CONDITION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, LABEL FLOATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331562 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367815 9210555 50382903678155

    Patients

    Seq Age Sex Outcome Treatment
    1 Other