BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE

    MDR report key: 8086064 · Received November 19, 2018

    Report

    Report Number
    2243072-2018-01626
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    November 1, 2018
    Report Date
    December 6, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. 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. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED (2) BD BLUE/BLACK SAFE-CLIPS FROM LOT # 7222543. CUSTOMER STATES THAT THE SAFE CLIPS ARE NOT CLIPPING. RETURNED SAFE CLIPS WERE EXAMINED UNDER THE MICROSCOPE AND THE CUTTING HOLE APPEARED CLEAR. THE SAFE CLIPS WERE TESTED AND WAS ABLE TO SUCCESSFULLY CUT NEEDLES. AS PER QE, A DHR REVIEW OF THE RISK MANAGEMENT FILE FOR THIS ISSUE SHOWS THAT THE RISK FOR THIS ISSUE IS LOW. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NOT CLIPPING ON LOT # 7222543. BASED ON THE SAMPLES/PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE CLIPPERS WEREN'T CLIPPING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFE-CLIP NEEDLE CLIPPING & STORAGE DEVICE CLIPPERS WEREN'T CLIPPING.

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS NYPRO, MX. 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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. 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 SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE CLIPPERS WEREN'T CLIPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927518 BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 7222543 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other