BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 G X 1 IN. BD ECLIPSE¿ HYPODERMIC NEEDLE

    MDR report key: 6126437 · Received November 23, 2016

    Report

    Report Number
    8041187-2016-00090
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 21, 2016
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: IT IS UNKNOWN IS A SAMPLE IS AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5141119. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THIS ISSUE. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. HOWEVER, CAPA (B)(4). HAS BEEN INITIATED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY SHIELD OF A 23 G X 1 IN. BD ECLIPSE¿ HYPODERMIC NEEDLE DISENGAGED DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776761 23 G X 1 IN. BD ECLIPSE¿ HYPODERMIC NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 5141119

    Patients

    Seq Age Sex Outcome Treatment
    1 Other