BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 17495458 · Received August 9, 2023

    Report

    Report Number
    1920898-2023-00550
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 10, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2234021. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 OF THE BD ULTRA-FINE¿ INSULIN SYRINGES SCALE WAS OUT OF ALIGNMENT. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THIS REPORT IS ABOUT SCALE MISALIGNMENT. THE TOP ONE SCALE WAS OUT OF ALIGNMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 OF THE BD ULTRA-FINE¿ INSULIN SYRINGES SCALE WAS OUT OF ALIGNMENT. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THIS REPORT IS ABOUT SCALE MISALIGNMENT. THE TOP ONE SCALE WAS OUT OF ALIGNMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892855 BD ULTRA-FINE¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2234021

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown