BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 5ML L/L NO NEEDLE

    MDR report key: 18527798 · Received January 16, 2024

    Report

    Report Number
    MW5150423
    Event Type
    Injury
    Date Received
    January 16, 2024
    Report Date
    January 10, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT'S DAUGHTER STATES THAT YESTERDAY EVENING, SHE WAS MIXING A CASSETTE FOR THE PATIENT AND THE 5ML SYRINGE MALFUNCTIONED. REMODULIN ENDED UP SPRAYING ON HER FACE AND HER HANDS. THEY WERE BURNING AND ARE STILL MILDLY BURNING TODAY. ADVISED PATIENT'S DAUGHTER TO SEEK MEDICATION ATTENTION TO ASSESS BURN. NO FURTHER INFORMATION; SYRINGE LOT NUMBER/EXPIRATION DATE NOT PROVIDED. IV REMODULIN PATIENT. WERE THERE MISSED ANY DOSES OR ADVERSE EVENTS EXPERIENCED AS A RESULT OF THE PRODUCT COMPLAINT? ADVERSE EVENT, SEE DESCRIPTION. DEFECTIVE AND / OR MALFUNCTIONING DEVICE / PRODUCT LOT NUMBER AND EXP DATE UNK. DOES THE PT HAVE THE DEFECTIVE AND / OR MALFUNCTIONING DEVICE / PRODUCT ON HAND IN CASE THE MFR REQUESTS A RETURN FOR FURTHER INVESTIGATION? UNK. REPORTED TO CVS/CAREMARK BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949067 SYRINGE 5ML L/L NO NEEDLE SYRINGE, PISTON FMF BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1 Female OPSUMIT| REMODULIN "VDV"