BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® NAF N2E PLUS BLOOD COLLECTION TUBES

    MDR report key: 9716886 · Received February 17, 2020

    Report

    Report Number
    1917413-2020-00130
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 28, 2020
    Report Date
    March 16, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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 FM, DAMAGED EPS TRAY AND DAMAGED CAP 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-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 8 BD VACUTAINER® NAF N2E PLUS BLOOD COLLECTION TUBES HAD BLACK FOREIGN MATTER IN THEM, 6 TUBES HAD PLASTIC PARTICLES FROM A BROKEN TRAY ENCAPSULATING THEM, AND 1 TUBE HAD A BROKEN CAP. ALL DEFECTS WERE FOUND BEFORE USE IN LOT# 9260618. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLACK POINT = 8 SP PLASTIC ENCAPSULATES TEAR PRODUCTS = 6 SP LID IS BROKEN = 1 SP".

    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 THAT 8 BD VACUTAINER® NAF N2E PLUS BLOOD COLLECTION TUBES HAD BLACK FOREIGN MATTER IN THEM, 6 TUBES HAD PLASTIC PARTICLES FROM A BROKEN TRAY ENCAPSULATING THEM, AND 1 TUBE HAD A BROKEN CAP. ALL DEFECTS WERE FOUND BEFORE USE IN LOT# 9260618. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLACK POINT = 8 SP. PLASTIC ENCAPSULATES TEAR PRODUCTS = 6 SP. LID IS BROKEN = 1 SP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181839 BD VACUTAINER® NAF N2E PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 9260618

    Patients

    Seq Age Sex Outcome Treatment
    1 Other