BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿+ INSULIN SYRINGE

    MDR report key: 14440259 · Received May 19, 2022

    Report

    Report Number
    1920898-2022-00349
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 27, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. 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# 8253871. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDR 1: (B)(6). INITIAL REPORTER ZIP: (B)(6). 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 THE BD MICRO-FINE¿+ INSULIN SYRINGE WAS UNABLE TO INJECT INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE DOES NOT LOOK THE SAME AS THE ONE HE HAS DIFFICULTY IN ADMINISTERING DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿+ INSULIN SYRINGE WAS UNABLE TO INJECT INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE DOES NOT LOOK THE SAME AS THE ONE HE HAS DIFFICULTY IN ADMINISTERING DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260882 BD MICRO-FINE¿+ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8253871

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown