BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 12367961 · Received August 25, 2021

    Report

    Report Number
    3002682307-2021-00438
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    July 16, 2021
    Report Date
    October 18, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    50382903057608
    PMA / PMN Number
    K100209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2011006. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, A PICTURE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, A SAFETY SHIELD DISENGAGED FROM THE NEEDLE CAN BE OBSERVED. BASED ON THE PICTURE SAMPLE ALONE, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT. EACH LOT PRODUCED IS TESTED FOR SAFETY SHIELD ACTIVATION PRIOR TO RELEASE. LOT NUMBER 2011006 WAS FOUND TO MEET ALL SPECIFICATIONS. THE ASSEMBLY PROCESS HAS A SYSTEM WHICH INSPECTS ALL PRODUCT FOR PROPER OPENING AND ACTIVATION OF THE SAFETY SHIELD AND ANY DEFECTS DETECTED ARE REJECTED. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED A SAFETY MECHANISM THAT DETACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE WAS DRAWING UP COVID VACCINE. WENT TO CLICK TO THE SAFETY DEVICE, SAME BROKE OFF.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED A SAFETY MECHANISM THAT DETACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE WAS DRAWING UP COVID VACCINE. WENT TO CLICK TO THE SAFETY DEVICE, SAME BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262281 BD ECLIPSE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 305760 2011006 50382903057608

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown