BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD ECLIPSE¿ NEEDLE

    MDR report key: 6711295 · Received July 13, 2017

    Report

    Report Number
    2243072-2017-00058
    Event Type
    Malfunction
    Date Received
    July 13, 2017
    Date of Event
    June 19, 2017
    Report Date
    August 14, 2017
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR TUAS ECLIPSE NEEDLES FROM 2/1/2015: CAPAS 46905 AND 56413 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. RESULTS: TWO PICTURES WERE RECEIVED AND OBSERVED. THE PICTURES SHOWED THE HUB WAS BROKEN AND THE SAFETY SHIELD WAS DISENGAGED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: BASED ON THE COMPLAINT VERBATIM, THE SAFETY SHIELD WAS BROKEN DUE TO THE USER PUSHING IT AGAINST THE BED AND IT BROKE OFF. WITHOUT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. A PHOTO IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE ATTEMPTED TO ENGAGE THE SAFETY SHIELD OF AN UNSPECIFIED BD ECLIPSE NEEDLE BY PUSHING IT AGAINST THE BED, AND IT BROKE OFF. THERE WAS NO REPORT OF ANY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490552 UNSPECIFIED BD ECLIPSE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other