BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 8101852 · Received November 26, 2018

    Report

    Report Number
    1920898-2018-00899
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    November 7, 2018
    Report Date
    November 19, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) 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 # 7170874 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD ULTRA-FINE¿ INSULIN SYRINGE THERE WAS AN ISSUE WITH PLUNGER MISSING/STERILE BREACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940500 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7170874

    Patients

    Seq Age Sex Outcome Treatment
    1 Other