BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAM

    MDR report key: 21154175 · Received January 14, 2025

    Report

    Report Number
    9617594-2025-00099
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    December 13, 2024
    Report Date
    April 1, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709076419
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN A2, A3, B5, D9, H10 AND NEW ATTACHMENT SECTION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY ONE (1) USED LIST# MC330027, 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 3 CLAMPS, LUER LOCK WAS RECEIVED AND VISUALLY INSPECTED. AS RECEIVED, THE TUBING WAS SEPARATED FROM THE TRIFUSE CONNECTOR. THE DIMENSIONS OF THE SEPARATED COMPONENTS WERE MEASURED AND FOUND TO MEET PRODUCT SPECIFICATIONS. THE SEPARATED COMPONENTS WERE EXAMINED UNDER A MICROSCOPE. EVIDENCE OF RESIDUAL TORN TUBING WITHIN THE TRIFUSE BOND POCKET. TUBING IS TORN, NOT CLEAN CUT. NO ADDITIONAL PHYSICAL DAMAGE OR OTHER ANOMALIES WERE OBSERVED. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE CUSTOMER COMPLAINT OF THE TUBING DISCONNECTED FROM THE TRIFUSE AND WHEN INSPECTING FURTHER THE PORT ON THE TRIFUSE WAS BROKEN IS CONFIRMED. THE PROBABLE CAUSE IS UNINTENTIONAL PULLING FORCE.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED VIA MEDSUN MEDWATCH MANDATORY AND VOLUNTARY REPORT WITH UF/IMPORTER REPORT # (B)(4) ON 15-JAN-2025. THE REPORT STATED: "UPON TRACING LINES, WE NOTICED THE LIPID TUBING WAS DISCONNECTED FROM THE TRIFUSE. WHEN INSPECTING FURTHER, THE PORT ON THE TRIFUSE WAS BROKEN IN AND LOCATED IN THE TRIFUSE. NEW LIPID TUBING WERE PRIMED WITH NEW LIPID SYRINGE AND NEW TRIFUSE WAS PRIMED/CHANGED OUT FOR PATIENT.¿ THE REPORT WAS COMPLETED BY MIKE LIGOCKI, A HEALTH PROFESSIONAL. THE CONTACT PERSON IS (B)(6) HOSPITAL. THE EVENT DATE IS DEC-2024, AND THE DATE REPORTED IS JAN-2025 AS INITIAL REPORT. THE EVENT OCCURRED AT THE HOSPITAL USER FACILITY. THE SUSPECTED MEDICAL DEVICE WAS A TRIFUSE WITH ITEM NUMBER MC330027 AND LOT NUMBER 14104635 WITH A COMMON DEVICE NAME STOPCOCK, I.V. SET WITH PROCODE FMG. EXPIRY DATE UNKNOWN. THIS A SINGLE-USE DEVICE AND WAS NOT REPROCESSED AND REUSED ON A PATIENT AND THIS DEVICE WAS NEVER SERVICED BY A THIRD-PARTY SERVICER. THE SAMPLE IS AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT, A 1-MONTH-OLD FEMALE AND THE RACE IS WHITE. NO PATIENT HARM AND DELAY IN THERAPY.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 3 CLAMPS, LUER LOCK WHERE IT WAS REPORTED UPON TRACING LINES AT 19:30 IT WAS NOTICED THE LIPID TUBING WAS DISCONNECTED FROM THE TRIFUSE. WHEN INSPECTING FURTHER THE PORT ON THE TRIFUSE WAS BROKEN IN AND LOCATED IN THE TRIFUSE. NEW LIPID TUBING WAS PRIMED WITH NEW LIPID SYRINGE AND NEW TRIFUSE WAS PRIMED/CHANGED OUT FOR PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256338 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAM STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14104635 00887709076419

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female LIPIDS, UNK MFR.