BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH

    MDR report key: 22947938 · Received September 2, 2025

    Report

    Report Number
    9617594-2025-01784
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    June 1, 2025
    Report Date
    September 2, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709069343
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE A PROBABLE CAUSE IS UNABLE TO BE DETERMINED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED DUE TO THE UNKNOWN LOT NUMBER.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED VIA A MEDWATCH REPORT # (B)(4) (ATTACHED). THE REPORT STATED "SINGLE LUMEN PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] WAS INFUSING AMPICILLIN. TECH CALLED RN TO BEDSIDE FOR BLOOD COMING OUT OF PICC. NURSE PAUSED FLUIDS AND CHECKED LINE. TRIFUSE EXTENSION APPEARED TO HAVE A LEAK. BLOOD HAD BACK UP AND WAS LEAKING OUT OF TRIFUSE EXTENSION. MANUFACTURER RESPONSE FOR EXTENSION SET, 9.5¿ 1.4 SMALLBORE TRIFUSE SET, 3 MICROCLAVE CLEAR, NANOCLAVE, 3 CHECK VALVES (PER SITE REPORTER). YES, THEY WERE MADE AWARE ON [DATE REDACTED]. CURRENTLY AWAITING MANUFACTURER RESPONSE." ADDITIONAL EVENT INFORMATION OBTAINED FROM UFMW: THE REPORT WAS COMPLETED BY (B)(6) A RISK MANAGER OF (B)(6) HOSPITAL. THE DATE OF THIS REPORT WAS ON JUL-2025. THIS IS A PRODUCT PROBLEM WITH THE EVENT DATE JUN-2025. THE OUTCOME ATTRIBUTED TO ADVERSE EVENT OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS. THE AGE OF THE PATIENT IS 13 DAYS OLD. THE SUSPECTED DEVICE IS A 9.5" (24 CM) SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 3 CHECK VALVES, 4 CLAMPS (YELLOW, LIGHT GREEN, 2 WHITE), LUER LOCK WITH LIST NUMBER A1141 AND UNKNOWN LOT NUMBER WITH PROCODE FMG, COMMON DEVICE NAME. THIS IS NOT SINGLE-USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT. THIS DEVICE WAS NOT SERVICED BY A THIRD-PARTY SERVICE. SAMPLE WAS AVAILABLE FOR EVALUATION. THIS IS AN INITIAL TYPE OF REPORT. THE LOCATION WHERE EVENT OCCURRED WAS IN HOSPITAL¿S PATIENT ROOM. THE REPORT WAS SENT TO THE MANUFACTURER. THE TYPE OF REPORTABLE EVENT IS MALFUNCTION. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT. CLIPORGO (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851759 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN 00887709069343

    Patients

    Seq Age Sex Outcome Treatment
    1 13 DA Unknown AMPICILLIN