BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 13252905 · Received January 13, 2022

    Report

    Report Number
    1920898-2021-01399
    Event Type
    Malfunction
    Date Received
    January 13, 2022
    Date of Event
    December 20, 2021
    Report Date
    January 20, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908418034
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. 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

    H6: 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# 0223914. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE, THE DEVICE EXPERIENCED THE CANNULA BREAKING OFF. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: NEEDLE BREAKING WHEN TRYING TO DO MY INJECTION. I HAVE HAD FIVE OF THEM BREAK WHILE TRYING TO USE THEM.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE, THE DEVICE EXPERIENCED THE CANNULA BREAKING OFF. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: NEEDLE BREAKING WHEN TRYING TO DO MY INJECTION. I HAVE HAD FIVE OF THEM BREAK WHILE TRYING TO USE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018031 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328418 0223914 00382908418034

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown