BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE

    MDR report key: 16502904 · Received March 8, 2023

    Report

    Report Number
    1920898-2023-00099
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 10, 2023
    Report Date
    March 17, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO PROVIDED. THE CUSTOMER RETURNED ONE PHOTO OF THE 30GX8MM BD SHELF CARTON. THE CUSTOMER REPORTED NO VENDOR LOT & NO EXPIRY DATE. THE PHOTO WAS EXAMINED, AND IT WAS OBSERVED THAT SHELF CARTON WAS MISSING THE LOT NUMBER, EXPIRATION DATE AND THE MANUFACTURER DATE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2173943. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE IMAGES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF LABEL INFORMATION MISSING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 100 BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE WAS MISSING INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO VENDOR LOT & NO EXPIRY DATE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 100 BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE WAS MISSING INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO VENDOR LOT & NO EXPIRY DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122364 BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 2173943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown