BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ HOME SHARPS CONTAINER, 1.4 QUART

    MDR report key: 17909498 · Received October 10, 2023

    Report

    Report Number
    2243072-2023-01821
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    September 27, 2023
    Report Date
    December 14, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    10885403960109
    PMA / PMN Number
    K072105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA/SA IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS PREMUIM PLASTIC SOLUTION (PPS). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1., AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ HOME SHARPS CONTAINER, 1.4 QUART THE SHARPS PIERCED THE WALL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED CALLER THOUGHT HE COULD INSERT A EPPE PEN INTO THE SHARPS CONTAINER. PLUS REMOVE THE NEEDLE FROM THE EPPE PEN ACCORDING TO THE DIRECTIONS ON THE BOX AS HE READ IT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ HOME SHARPS CONTAINER, 1.4 QUART THE SHARPS PIERCED THE WALL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED CALLER THOUGHT HE COULD INSERT A EPPE PEN INTO THE SHARPS CONTAINER. PLUS REMOVE THE NEEDLE FROM THE EPPE PEN ACCORDING TO THE DIRECTIONS ON THE BOX AS HE READ IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163912 BD¿ HOME SHARPS CONTAINER, 1.4 QUART HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN 10885403960109

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown