BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE

    MDR report key: 17637779 · Received August 28, 2023

    Report

    Report Number
    1920898-2023-00585
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    August 9, 2023
    Report Date
    September 14, 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

    H3. 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

    INVESTIGATION SUMMARY: 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# 2234021. ALL INSPECTION PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE HAD FOREIGN MATTER ON THE TIP OF THE NEEDLE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THIS REPORT IS ABOUT FM ON THE NEEDLE TIP. FM (LIKE A DROP OF WATER) WAS ON THE TIP OF THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE HAD FOREIGN MATTER ON THE TIP OF THE NEEDLE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THIS REPORT IS ABOUT FM ON THE NEEDLE TIP. FM (LIKE A DROP OF WATER) WAS ON THE TIP OF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726652 BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2234021

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown