BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 14465232 · Received May 21, 2022

    Report

    Report Number
    1920898-2022-00357
    Event Type
    Malfunction
    Date Received
    May 21, 2022
    Date of Event
    May 9, 2022
    Report Date
    June 7, 2022
    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

    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

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 1/2CC, 12.7MM SYRINGE. CUSTOMER STATES THAT THE BARREL IS DAMAGED. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A PIECE OF THE BARREL BROKEN OFF RANGING FROM THE 0-10 UNIT MARKINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1242322. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN SYRINGE BARREL WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "ACCORDING TO THE CUSTOMER'S REPORT, UPON UNPACKING, THE HCP NOTICED THAT THERE WAS A HOLE ON THE BARREL."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN SYRINGE BARREL WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "ACCORDING TO THE CUSTOMER'S REPORT, UPON UNPACKING, THE HCP NOTICED THAT THERE WAS A HOLE ON THE BARREL.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368216 BD ULTRA-FINE¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1242322

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown