BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    27 G X 1/2 IN. BD ECLIPSE¿ NEEDLE

    MDR report key: 6437177 · Received March 27, 2017

    Report

    Report Number
    8041187-2017-00032
    Event Type
    Malfunction
    Date Received
    March 27, 2017
    Date of Event
    March 6, 2017
    Report Date
    March 27, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. 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. REMEDIAL ACTION REQUIRED: CAPAS (B)(4) WERE OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. ADDITIONALLY, FIELD ACTION NOTIFICATION MSS-16-837-FA WAS INITIATED AND A PRODUCT ADVISORY LETTER WAS SENT ON 12/29/2016. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE MULTIPLE INCIDENTS WHERE THE SAFETY MECHANISM OF A 27 G X 1/2 IN. BD ECLIPSE¿ NEEDLE FAILED POST USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217286 27 G X 1/2 IN. BD ECLIPSE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other