BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SHARPS COLLECTOR

    MDR report key: 8074655 · Received November 15, 2018

    Report

    Report Number
    2243072-2018-01602
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 26, 2018
    Report Date
    November 14, 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
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INVESTIGATION SUMMARY: 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: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LID OF THE BD¿ SHARPS COLLECTOR WOULD NOT ATTACH. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912591 BD¿ SHARPS COLLECTOR HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 8094001 10885403960109

    Patients

    Seq Age Sex Outcome Treatment
    1 Other