BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SHARPS COLL 1.5QT RED

    MDR report key: 9699953 · Received February 12, 2020

    Report

    Report Number
    2243072-2020-00187
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    January 17, 2020
    Report Date
    February 28, 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: NO SAMPLES OR PICTURES WERE RECEIVED. THREE ATTEMPTS TO GET MORE INFORMATION OR PICTURES WERE MADE, HOWEVER IN NONE OF THE CASES ADDITIONAL INFORMATION WERE PROVIDED. 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. BASED ON INFORMATION PROVIDED IT WASN¿T POSSIBLE DETERMINE THE ROOT CAUSE LIKE A FAILURE MODE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS NOT ENOUGH INFORMATION OR EVIDENCE TO CONFIRM A FAILURE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESES TO ENGLISH. VERBATIM: ¿THE TEMPORARY LIDS OPEN AFTER CLOSING¿.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION 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 THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH. VERBATIM: ¿THE TEMPORARY LIDS OPEN AFTER CLOSING.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166930 BD SHARPS COLL 1.5QT RED SHARPS CONTAINER FMI BECTON DICKINSON 50382903054874

    Patients

    Seq Age Sex Outcome Treatment
    1 Other