BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    110" 15 DROP PRIMARY SET W/2 CLAVE¿ REMV 2 GANG 4-WAY STOPCOCKS,2 CHECK VALVES,

    MDR report key: 17511229 · Received August 11, 2023

    Report

    Report Number
    9617594-2023-00535
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 1, 2023
    Report Date
    July 18, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709012523
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF DEFECTIVE/MALFUNCTIONING COMPONENTS ON ITEM B90111 COULD NOT BE CONFIRMED BY INVESTIGATION. SINCE NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY REVIEW (DHR) FOR LOT 6050629 WAS REVIEWED AND NO NON CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 110" 15 DROP PRIMARY SET W/2 CLAVE¿ REMV 2 GANG 4-WAY STOPCOCKS,2 CHECK VALVES, ROTATING LUER, 1 EXT, WHERE IT WAS REPORTED THE INTRAVENOUS (IV) TUBE IS NOT WORKING PROPERLY. THE CUSTOMER STATED THAT THEY CAN PRIME THE TUBING, BUT ONCE HOOKED UP TO A PATIENT IT DOES NOT RUN CORRECTLY. FURTHERMORE, IF THE CUSTOMER TAKES THE FIRST PART OF THE TUBING OFF AT THE STOPCOCK, IT SEEMS TO WORK, BUT THEY NEED THIS PIECE ATTACHED. THE CUSTOMER REPORTED THAT THE SEPARATION/ DISCONNECTION OCCURS IF LATTER PART OF STOPCOCK IS DISCONNECTED. IT WAS REPORTED THAT TUBING HAS BEEN HOOKED UP TO PATIENTS AND THEN HAD TO BE CHANGED. THERE WAS PATIENT INVOLVEMENT, BUT NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763278 110" 15 DROP PRIMARY SET W/2 CLAVE¿ REMV 2 GANG 4-WAY STOPCOCKS,2 CHECK VALVES, STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6050629 00887709012523

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown LACTATED RINGER'S, UNK MFR