BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NESTABLE SHARPS COLLECTOR

    MDR report key: 9758270 · Received February 26, 2020

    Report

    Report Number
    2243072-2020-00286
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    February 6, 2020
    Report Date
    March 25, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903054874
    PMA / PMN Number
    K943139
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: DHR REVIEW PROCESS CAN¿T BE PERFORMED BECAUSE THE LOT NUMBER WASN¿T PROVIDED A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE TEMPORARY LID DIDN¿T CLOSE FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. ACCORDING TO INFORMATION PROVIDED FROM CUSTOMER AN EXHAUSTIVE INVESTIGATION CAN NOT BE PERFORMED SINCE THERE ARE NO SAMPLES TO EVALUATE THIS FAILURE MODE (TEMPORARY LID OPENED). ADDITIONAL INFORMATION IS NEEDED TO DETERMINE THE ROOT CAUSE OF THIS ISSUE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ NESTABLE SHARPS COLLECTOR LID OPENS. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TEMPORARY LID OPENS.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. 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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ NESTABLE SHARPS COLLECTOR LID OPENS. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TEMPORARY LID OPENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223181 BD NESTABLE SHARPS COLLECTOR HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 1075C5 50382903054874

    Patients

    Seq Age Sex Outcome Treatment
    1 Other