BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM

    MDR report key: 19579782 · Received June 21, 2024

    Report

    Report Number
    3023359743-2024-00222
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    May 29, 2024
    Report Date
    September 10, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED TO SECTIONS B4, G6, H2, H3, AND H11. CORRECTIONS MADE TO SECTION H6 (TYPE OF INVESTIGATION & INVESTIGATION CONCLUSIONS). INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    THE CDE IN THE HOSPITAL REPORTED THAT AN INTERNAL IMS HAD BEEN RECORDED PERTAINING TO THE USE OF AUTOSHIELD DUO IN PAEDIATRIC PATIENTS AT THE HOSPITAL NBH PAEDIATRICS RECENTLY RECEIVED A CALL FROM RNSH POST TRANSFER OF TWO YOUNG PATIENTS WITH NEWLY DIAGNOSED TYPE 1 DIABETES, CHECKING THAT INSULIN HAD BEEN CORRECTLY ADMINISTERED WHILST AT NBH. PAED STAFF HAD USED THE BD AUTOSHIELD DUO SAFETY PEN NEEDLES AS THEY HAD BEEN TRAINED TO. I HAVE CHECKED TECHNIQUE WITH CNE XXXXX, THE PEN NEEDLES HAVE BEEN USED CORRECTLY WITH INSULIN PENS. WITH ONE PATIENT, NBH STAFF GAVE THE LAST INSULIN DOSE VIA INSULIN SYRINGE RATHER THAN USE THE BD AUTOSHIELD DUO SAFETY PEN NEEDLE, AND THE BGLS SUBSEQUENTLY IMPROVED. ED DIRECTLY TRANSFERRED OUT TWO OTHER YOUNG PATIENTS WITH NEW TYPE 1 DIABETES DIAGNOSES, ALSO HAD CONCERNS ABOUT USING THE BD AUTOSHIELD DUO SAFETY PEN NEEDLES, AND SUBSEQUENTLY CONTACTED ME. DUE TO THE WAY THE PEN NEEDLE FUNCTIONS, STAFF DON¿T FEEL CONFIDENT A DOSE OF INSULIN HAS BEEN FULLY DELIVERED AS THEY CAN¿T SEE THE NEEDLE INSERT AND OFTEN SEE FLUID ON THE SKIN. THE CALL FROM RNSH STRENGTHENED THIS CONCERN. THE PEN NEEDLE ALSO REQUIRES SIGNIFICANT FORCE TO ACTIVATE THE NEEDLE INSERTION, WHICH IS UNPLEASANT ON YOUNG BODIES. STAFF ARE AWARE A GENTLE SKIN HOLD IS REQUIRED FOR SMALL BODIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164051 PEN NEEDLE AUTOSHIELD DUO 30GX5MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 329505 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown