BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ SHORT NEEDLE INSULIN SYRINGES

    MDR report key: 14860228 · Received June 29, 2022

    Report

    Report Number
    1920898-2022-00422
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    June 1, 2022
    Report Date
    June 23, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1173030. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 100 UNIT PACKAGES WERE UNSEALED ON THE BD ULTRA-FINE¿ SHORT NEEDLE INSULIN SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ASP WERE PACKING THEIR KITS AND FOUND UNSEALED PACKAGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365952 BD ULTRA-FINE¿ SHORT NEEDLE INSULIN SYRINGES HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 1173030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown