BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMC PISTON SYRINGE

    MDR report key: 4631286 · Received March 20, 2015

    Report

    Report Number
    1423625-2015-00001
    Event Type
    Malfunction
    Date Received
    March 20, 2015
    Date of Event
    February 1, 2015
    Report Date
    February 19, 2015
    Manufacturer
    INTL. MEDSURG CONNECTION, INC.
    Product Code
    FMF
    PMA / PMN Number
    K102969
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A 60CC SYRINGE SPLIT WHILE DOING A BEDSIDE PERICENTESIS. THE RESIDENT WAS SPLASHED IN THE FACE WITH THE FLUID. NO INJURY TO THE RESIDENT WAS REPORTED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO PATIENT IMPACT. EVALUATION OF THE RETURNED SAMPLE CONFIRMED A CRACK IN THE BARREL OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191748 IMC PISTON SYRINGE SYRINGE FMF INTL. MEDSURG CONNECTION, INC. 300-60LL 13-7818-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other