BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ HYPODERMIC NEEDLE

    MDR report key: 7173024 · Received January 8, 2018

    Report

    Report Number
    8041187-2017-00282
    Event Type
    Malfunction
    Date Received
    January 8, 2018
    Date of Event
    December 14, 2017
    Report Date
    December 19, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057635
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION: 2 REPRESENTATIVE SAMPLES OF BATCH 5141109 WERE RETURNED IN SEALED PACKAGES FOR INVESTIGATION. THE SAFETY SHIELDS WERE FOUND TO BE INTACT AND PASSED SAFETY SHIELD TEST. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBERS. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MORE, THEREFORE A ROOT CAUSE CANNOT BE DETERMINED. CAPA (B)(4) WAS INITIATED FOR THIS ISSUE TO DOCUMENT THE INVESTIGATION PATH, ROOT CAUSE ANALYSIS AND REMEDIATION PLAN TO INCLUDE CORRECTIVE AND PREVENTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY SHIELD ON A BD ECLIPSE¿ HYPODERMIC NEEDLE FELL OFF BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17455 BD ECLIPSE¿ HYPODERMIC NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 5141109 30382903057635

    Patients

    Seq Age Sex Outcome Treatment
    1 Other