BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SHARPS DISPOSAL

    MDR report key: 18976667 · Received March 26, 2024

    Report

    Report Number
    2243072-2024-00444
    Event Type
    Malfunction
    Date Received
    March 26, 2024
    Date of Event
    March 1, 2024
    Report Date
    September 25, 2024
    Manufacturer
    BD MEDICAL, MEDICATION DELIVERY SOLUTIONS
    Product Code
    FMI
    UDI-DI
    00382903056040
    PMA / PMN Number
    K943140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED AND INVESTIGATED BY OUR QUALITY TEAM. THE LID ON CONTAINER WOULD NOT SHUT AS CUSTOMER COMPLAINT MENTIONED AND THE COMPLAINT HAS BEEN VERIFIED. THE SUPPLIER WAS CONTACTED FOR POSSIBLE ROOT CAUSE AND THE DETERMINED ISSUE WAS MOST LIKELY DUE TO INCORRECT GASKET DIMENSIONS(THICKNESS) DURING PRODUCTION. DEVICE HISTORY RECORD REVIEW TO VERIFY IF DURING THE MANUFACTURING PROCESS THERE WERE ISSUES REPORTED FOR LID WILL NOT SHUT FOR LOT 4030953 MANUFACTURED ON 02/03/2024 AND LOT 4030941 MANUFACTURED ON 02/01/2024, WHICH HAD NO ISSUES FOUND. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULTS EXHIBIT NO ISSUE REPORTED FOR THE SAME PART NUMBER AND ISSUE THROUGHOUT THE LAST TWELVE MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SHARPS DISPOSAL LID WAS DIFFICULT TO CLOSE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: THE SHARPS COLLECTORS WILL NOT CLOSE CORRECTLY WHICH IS A SAFETY HAZARD. OUR INFUSION NURSES ARE REPORTING THAT IT IS MUCH MORE DIFFICULT TO CLOSE/SECURE THE LIDS OF THE YELLOW BINS, COMPARED TO BEFORE. THEY HAVE TO SNAP THEM ON, AND THEY ARE REPORTING IT IS HARDER TO DO. EVS PICKS THESE BINS UP, WHEN THEY ARE ¾ FULL, IN THE END OF THE DAY, AND WE HAD AT LEAST ONE INSTANCE, WHEN THE BIN¿S LID WAS NOT FULLY SECURED, AND THE TRACE CHEMOTHERAPY SPILLED OUT. SO THERE ARE POTENTIAL ERGONOMICS ISSUES, AND SAFETY ISSUE FOR BOTH INFUSION AND EVS TEAM. PRODUCT#: 305604.

    Description of Event or Problem · 0

    SAMPLES RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4378 BD SHARPS DISPOSAL HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL, MEDICATION DELIVERY SOLUTIONS UNKNOWN 00382903056040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown