BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER

    MDR report key: 7526838 · Received May 18, 2018

    Report

    Report Number
    9617032-2018-02215
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    December 5, 2017
    Report Date
    May 3, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7235953, MEDICAL DEVICE EXPIRATION DATE: 08/31/2020, DEVICE MANUFACTURE DATE: 08/23/2017, MEDICAL DEVICE LOT #: 7262855, MEDICAL DEVICE EXPIRATION DATE: 09/30/2020, DEVICE MANUFACTURE DATE: 09/19/2017, MEDICAL DEVICE LOT #: 7173925, MEDICAL DEVICE EXPIRATION DATE: 08/31/2020, DEVICE MANUFACTURE DATE: 06/22/2017, MEDICAL DEVICE LOT #: 7173924, MEDICAL DEVICE EXPIRATION DATE: 08/31/2020, DEVICE MANUFACTURE DATE: 06/22/2017. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE 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® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER HAD TUBE PUSH OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368329 BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 7173922

    Patients

    Seq Age Sex Outcome Treatment
    1 Other