BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II INSULIN SYRINGE

    MDR report key: 16782358 · Received April 20, 2023

    Report

    Report Number
    1920898-2023-00247
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    April 1, 2023
    Report Date
    May 18, 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# (B)(4). ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE LOT #: LOT 2052388 WAS REPORTED; HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCALE ON THE BD ULTRA-FINE¿ II INSULIN SYRINGE WAS MISALIGNED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE USER REPORTED THAT THE SCALE WAS MISALIGNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCALE ON THE BD ULTRA-FINE¿ II INSULIN SYRINGE WAS MISALIGNED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE USER REPORTED THAT THE SCALE WAS MISALIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966275 BD ULTRA-FINE¿ II INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2052388

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown