BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML L/L NO NEEDLE

    MDR report key: 16445517 · Received February 24, 2023

    Report

    Report Number
    MW5115221
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    February 15, 2023
    Report Date
    February 15, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CAREGIVER REPORTED THAT DURING PREPARATION OF TODAY'S MIX, PATIENT USED SYRINGE THAT HAD CRACK AND WASTED AROUND 5 ML OF TREPROSTINIL. SHE DID NOT NEED TO ORDER TREPROSTINIL OR DURABLE MEDICAL EQUIPMENT TODAY. SHE INFORMED ME THAT IF ANY ISSUES WITH SYRINGE WITH THE NEXT MIX ON FRIDAY, SHE WILL CALL US AND WE WILL SHIP TREPROSTINIL AND SUPPLIES. THERE WAS NO INTERRUPTION IN TREPROSTINIL TREATMENT. AFFECTED SYRINGE 5 ML - LOT NUMBER 2347963/EXPIRATION DATE UNK. PATIENT WAS INSTRUCTED TO KEEP THE DEFECTIVE SYRINGE IN CASE NEEDED FOR RETURN. NO SIDE EFFECTS FROM DEFECTIVE DEVICE REPORTED. NO ADDITIONAL INFORMATION AVAILABLE. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857073 SYRINGE 5ML L/L NO NEEDLE SYRINGE, PISTON FMF BECTON DICKINSON 2347963

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male