BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SHARPS COLLECTOR

    MDR report key: 7934788 · Received October 4, 2018

    Report

    Report Number
    2243072-2018-01416
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    September 10, 2018
    Report Date
    September 26, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    10885403960109
    PMA / PMN Number
    K943139
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR DAMAGED/CRACKED ON LOT # 8082001. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. AS PER QE, A DHR REVIEW OF THE RISK MANAGEMENT FILE FOR THIS ISSUE SHOWS THAT THE RISK FOR THIS ISSUE IS LOW. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD¿ SHARPS COLLECTOR HAD CRACK IN THE NECK OF THE LID. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777622 BD¿ SHARPS COLLECTOR SHARPS COLLECTOR FMI BECTON DICKINSON 8082001 10885403960109

    Patients

    Seq Age Sex Outcome Treatment
    1 Other