BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 1 IN. BD ECLIPSE¿ NEEDLE

    MDR report key: 5377856 · Received January 19, 2016

    Report

    Report Number
    8041187-2016-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2016
    Date of Event
    December 15, 2015
    Report Date
    January 5, 2016
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: THIS INCIDENT WAS NOTIFIED TO THE FDA VIA MEDWATCH REF 5058624. NO REPORTER INFORMATION WAS PROVIDED IN THIS REPORT. THEREFORE, (B)(4) WAS USED AS THE REPORTER STATE AS THIS IS FROM WHERE THE MEDWATCH WAS SENT. DEVICE EVALUATION: RESULT - A SAMPLE WAS NOT RECEIVED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5169164. A MANUFACTURING REVIEW REVEALS THE DEFECT WAS NOT INFLUENCED BY PREVENTIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT. CONCLUSIONS - AS THERE WAS NO ACTUAL RETURNED SAMPLE FOR EVALUATION, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. OF NOTE, CAPA (B)(4) HAS BEEN OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ECLIPSE NEEDLE ACTIVATED COVER BROKE OFF WHEN THE NURSE ATTEMPTED TO COVER THE NEEDLE, CAUSING A NEEDLE STICK. THE NEEDLE WAS BEING USED FOR INJECTING MEDICATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37197 25 G X 1 IN. BD ECLIPSE¿ NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 5169164

    Patients

    Seq Age Sex Outcome Treatment
    1 Other