BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO

    MDR report key: 17030079 · Received May 31, 2023

    Report

    Report Number
    17030079
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 19, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PIV STARTED. ATTEMPTED TO ASPIRATE BLOOD TO COLLECT LAB SPECIMEN, BUT MOSTLY AIR WAS ASPIRATED INTO STERILE SYRINGE. TROUBLESHOOTED SYRINGE AND PIV EXTENSION PIECE. ATTEMPTED TO FLUSH PIV WITH SALINE DIRECTLY AT CATHETER HUB. DURING FLUSH, SALINE WAS OBSERVED LEAKING FROM CATHETER NEAR HUB. PIV REMOVED AND ANOTHER RESTARTED BY OTHER CLINICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837571 JELCO CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ SMITHS MEDICAL ASD, INC. 328300 4260883 OR 4335871

    Patients

    Seq Age Sex Outcome Treatment
    1 120 DA Female