BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD MICROFINE PLUS PEN NEEDLE

    MDR report key: 11346776 · Received February 18, 2021

    Report

    Report Number
    2243072-2021-00401
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 25, 2021
    Report Date
    March 26, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. DHR COULD NOT BE PERFORMED DUE TO UNKNOWN LOT#.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD MICROFINE PLUS¿ PEN NEEDLE WAS DIFFICULT TO OPERATE AND SOMETIMES INJECTED MORE OR LESS THAN "1.5 IU" OF INSULIN LISPRO. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) (HUMALOG) INJECTIONS FROM CARTRIDGE VIA REUSABLE PEN (HUMAPEN LUXURA HD), 1.5 IU AT UNKNOWN FREQUENCY VIA AN UNKNOWN ROUTE, FOR THE TREATMENT OF DIABETES MELLITUS, BEGINNING ON AN UNKNOWN DATE APPROXIMATELY IN (B)(6) 2019. SINCE AN UNKNOWN DATE, WHILE ON INSULIN LISPRO THERAPY, HE (PATIENT'S FATHER) BELIEVED THE PEN SOMETIMES GAVE INSULIN LISPRO LESS AND SOMETIMES GAVE INSULIN LISPRO MORE, WHEN DOSE WAS SET AT 1.5 IU. BD MICROFINE NEEDLE TIP WAS BEING USED. THERE WAS NO CRASHING OR FALLING DOWN OF PEN (B)(4). INFORMATION REGARDING CORRECTIVE TREATMENT AND THE OUTCOME OF THE EVENT WAS NOT PROVIDED. INSULIN LISPRO THERAPY WAS ONGOING. THE OPERATOR OF THE HUMAPEN LUXURA HD AND HIS/ HER TRAINING STATUS WAS NOT PROVIDED. THE HUMAPEN LUXURA HD MODEL DURATION OF USE AND THE REPORTED HUMAPEN LUXURA HD DURATION OF USE WAS NOT PROVIDED BUT STARTED ON AN UNKNOWN DATE IN (B)(6) 2019. THE ACTION TAKEN WITH HUMAPEN LUXURA HD AND ITS RETURN STATUS WAS UNKNOWN. THE REPORTING CONSUMER DID NOT PROVIDE RELATEDNESS FOR THE EVENT WITH INSULIN LISPRO DRUG AND RELATED THE EVENT TO HUMAPEN LUXURA HD."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD MICROFINE PLUS¿ PEN NEEDLE WAS DIFFICULT TO OPERATE AND SOMETIMES INJECTED MORE OR LESS THAN "1.5 IU" OF INSULIN LISPRO. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) (HUMALOG) INJECTIONS FROM CARTRIDGE VIA REUSABLE PEN (HUMAPEN LUXURA HD), 1.5 IU AT UNKNOWN FREQUENCY VIA AN UNKNOWN ROUTE, FOR THE TREATMENT OF DIABETES MELLITUS, BEGINNING ON AN UNKNOWN DATE APPROXIMATELY IN (B)(6) 2019. SINCE AN UNKNOWN DATE, WHILE ON INSULIN LISPRO THERAPY, HE (PATIENT'S FATHER) BELIEVED THE PEN SOMETIMES GAVE INSULIN LISPRO LESS AND SOMETIMES GAVE INSULIN LISPRO MORE, WHEN DOSE WAS SET AT 1.5 IU. BD MICROFINE NEEDLE TIP WAS BEING USED. THERE WAS NO CRASHING OR FALLING DOWN OF PEN ((B)(4), LOT UNKNOWN). INFORMATION REGARDING CORRECTIVE TREATMENT AND THE OUTCOME OF THE EVENT WAS NOT PROVIDED. INSULIN LISPRO THERAPY WAS ONGOING. THE OPERATOR OF THE HUMAPEN LUXURA HD AND HIS/ HER TRAINING STATUS WAS NOT PROVIDED. THE HUMAPEN LUXURA HD MODEL DURATION OF USE AND THE REPORTED HUMAPEN LUXURA HD DURATION OF USE WAS NOT PROVIDED BUT STARTED ON AN UNKNOWN DATE IN (B)(6) 2019. THE ACTION TAKEN WITH HUMAPEN LUXURA HD AND ITS RETURN STATUS WAS UNKNOWN. THE REPORTING CONSUMER DID NOT PROVIDE RELATEDNESS FOR THE EVENT WITH INSULIN LISPRO DRUG AND RELATED THE EVENT TO HUMAPEN LUXURA HD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238189 UNSPECIFIED BD MICROFINE PLUS PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1