BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    MDR report key: 7222806 · Received January 26, 2018

    Report

    Report Number
    1024879-2018-00039
    Event Type
    Injury
    Date Received
    January 26, 2018
    Date of Event
    November 16, 2017
    Report Date
    January 29, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER 7243784 WAS REPORTED, HOWEVER WAS NOT FOUND FOR THE REPORTED CATALOG NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    CORRECTION: AFTER FURTHER EVALUATION, IT HAS BEEN DETERMINED THAT THIS COMPLAINT IS A DUPLICATE OF A PREVIOUSLY SUBMITTED COMPLAINT: MFR REPORT # 1024879-2017-01288. PATIENT IDENTIFIER (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE SAFETY DETACHED FROM A BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER, LEAVING THE USED NEEDLE EXPOSED AND CONTRIBUTED TO A DIRTY NEEDLE STICK RECEIVED BY THE USER. THE NEEDLE STICK WAS WASHED AND THE USER "REPORTED TO OCCUPATIONAL HEALTH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67087 BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER BLOOD COLLECTION NEEDLE JKA BECTON, DICKINSON & CO., (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention