BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 18417961 · Received December 29, 2023

    Report

    Report Number
    2243072-2023-02254
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    December 8, 2023
    Report Date
    May 2, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A 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 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. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN

    Additional Manufacturer Narrative · 0

    D9: DEVICE AVAILABLE FOR EVAL? SAMPLES RECEIVED FOR 8MM SYRINGE/LOT # 3142983 (PER SAP, CAT # 328822) IS CAPTURED IN ETQ COMPLAINT # (B)(4). H.6 INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR UNKNOWN LOT# 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING THE BD ULTRA-FINE¿ INSULIN SYRINGE INACCURATE SCALE MARKINGS WERE FOUND SEVERALLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INACCURATE SCALEMARKS ON PRODUCTS WERE FOUND. (SEVERAL TIMES)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING THE BD ULTRA-FINE¿ INSULIN SYRINGE INACCURATE SCALE MARKINGS WERE FOUND SEVERALLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INACCURATE SCALEMARKS ON PRODUCTS WERE FOUND. (SEVERAL TIMES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236399 BD ULTRA-FINE¿ INSULIN SYRINGE PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown