BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT)

    MDR report key: 17733194 · Received September 12, 2023

    Report

    Report Number
    1920898-2023-00612
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    August 24, 2023
    Report Date
    October 12, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    00382903295159
    PMA / PMN Number
    K223286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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. DUE TO THE BATCH BEING UNKNOWN, NO DHR REVIEW CAN BE COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT) THE CANNULA BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: NEEDLE, BROKEN OFF IN THE INSULIN PEN. PER UC DAVIS A NURSE WAS ADMINISTERING INSULIN FROM A NOVOLOG PEN WHEN IT STOPPED HALFWAY THROUGH. WHEN THE NURSE UNSCREWED THE NEEDLE, THE SAFETY HAD ENGAGED, BUT SHE NOTICED PART OF THE NEEDLE HAD BROKEN OFF INSIDE THE PEN ITSELF.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT) THE CANNULA BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: NEEDLE, BROKEN OFF IN THE INSULIN PEN. PER UC DAVIS A NURSE WAS ADMINISTERING INSULIN FROM A NOVOLOG PEN WHEN IT STOPPED HALFWAY THROUGH. WHEN THE NURSE UNSCREWED THE NEEDLE, THE SAFETY HAD ENGAGED, BUT SHE NOTICED PART OF THE NEEDLE HAD BROKEN OFF INSIDE THE PEN ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861792 BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE UNKNOWN 00382903295159

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown