BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 17628118 · Received August 25, 2023

    Report

    Report Number
    1920898-2023-00582
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Date of Event
    August 1, 2023
    Report Date
    September 1, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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# 1242485. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1: INITIAL REPORTER PHONE #: (B)(6). 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 WHILE USING THE BD ULTRA-FINE¿ INSULIN SYRINGE WAS UNABLE TO INJECT INSULIN. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT ON AUGUST 2ND, 2023, AND REPORTED THAT THE DISPOSABLE STERILE INSULIN SYRINGE PURCHASED A FEW DAYS AGO HAD DIFFICULTY IN ADVANCING DURING SELF-USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD ULTRA-FINE¿ INSULIN SYRINGE WAS UNABLE TO INJECT INSULIN. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT ON (B)(6) 2023, AND REPORTED THAT THE DISPOSABLE STERILE INSULIN SYRINGE PURCHASED A FEW DAYS AGO HAD DIFFICULTY IN ADVANCING DURING SELF-USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815104 BD ULTRA-FINE¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1242485

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown