BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONO SYRINGE 10ML

    MDR report key: 19776960 · Received July 17, 2024

    Report

    Report Number
    MW5157379
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 25, 2024
    Report Date
    June 25, 2024
    Manufacturer
    PENTAFERTE ITALIA S.R.L.
    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

    SPONTANEOUS REPORT. NURSE FROM (B)(6) CALLED TO LET US KNOW THE CRONO SYRINGE WAS DEFECTIVE. SHE SAID SHE DREW UP THE MEDICATION, AND THE RUBBER STOPPER IN SYRINGE CAME DISCONNECTED FROM PLUNGER AND THE MEDICATION ENDED UP ON THE TABLE. UNKNOWN IF PT MISSED A DOSE OR EXPERIENCED AN ADVERSE EVENT, UNKNOWN IF DEFECTIVE DEVICE IS AVAILABLE FOR RETURN. REPORTED TO (B)(6) BY: HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220994 CRONO SYRINGE 10ML SYRINGE, PISTON FMF PENTAFERTE ITALIA S.R.L.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male RYSTIGGO SDV.