BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-FLO(TM)4-WAY STOPCOCK W/SWIVEL MALE LUER LOCK

    MDR report key: 17660711 · Received August 31, 2023

    Report

    Report Number
    17660711
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    August 15, 2023
    Report Date
    August 25, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    S: NOTIFIED BY RN THAT SHE DISCONNECTED ARTERIAL ACCESS LINE (ON CRRT) IN ORDER TO FLUSH THE HD LINE BECAUSE THE ACCESS LINE WAS ALARMING FOR NEGATIVE PRESSURES. WHEN RN RECONNECTED THE STOPCOCK THE LUER LOCK SEPARATED FROM THE STOPCOCK A: RN GOT A NEW STOPCOCK TO REPLACE BROKEN ONE R: WRITING INCIDENT REPORT FOR TRENDING PURPOSES ON MALFUNCTIONED STOPCOCK UNFORTUNATELY CANNOT CONFIRM THAT IT SHARED THE SAME LOT NUMBER AS THE STOP COCKS ARE PLACED UPON INITIAL PUMP SET UP AND IT LIKELY WAS TAKEN FROM THE SUPPLY ROOM BUT UNSURE HOW OFTEN THE STOPCOCK SUPPLY IS ROTATED. THE LOT MENTIONED IS OUR BEST GUESS. CURRENT AVAILABLE PRODUCT ON UNIT HAS THE FOLLOWING INFO FOR MED SUN REPORT: REF MX9341L, NAME: HI-FLO(TM)4-WAY STOPCOCK W/SWIVEL MALE LUER LOCK, MANUFACTURER: SMITHS MEDICAL ASD, LOT : 4391592.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149478 HI-FLO(TM)4-WAY STOPCOCK W/SWIVEL MALE LUER LOCK STOPCOCK, I.V. SET FMG SMITHS MEDICAL ASD, INC. MX9341L 4391592 (CURRENT STOCK)

    Patients

    Seq Age Sex Outcome Treatment
    1 4015 DA Male