BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7507162 · Received May 11, 2018

    Report

    Report Number
    9617032-2018-02165
    Event Type
    Malfunction
    Date Received
    May 11, 2018
    Date of Event
    November 27, 2017
    Report Date
    May 22, 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 · 0

    "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 #: 7151626. MEDICAL DEVICE EXPIRATION DATE: 05/31/2020. DEVICE MANUFACTURE DATE: 05/31/2017.

    Additional Manufacturer Narrative · 1

    (B)(6). BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT 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 THE TUBE PUSHED OFF OF THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER. NO MEDICAL INTERVENTIONS OR SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348284 BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 7173924

    Patients

    Seq Age Sex Outcome Treatment
    1 Other