BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    41 CM (16") APPX 2.7ML, EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE®, LUER CHECK

    MDR report key: 24050115 · Received January 12, 2026

    Report

    Report Number
    9617594-2026-00020
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 1, 2025
    Report Date
    March 11, 2026
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED ONE (1) USED. LIST #011-H1225, 41 CM (16") APPX 2.7ML, EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE®, LUER CHECK VALVE; LOT #UNKNOWN. A CRACK WAS OBSERVED ON THE BAG SPIKE BODY. THE REPORTED COMPLAINT OF A LEAK COULD BE CONFIRMED. THE RETURNED SAMPLE WAS OBSERVED TO HAVE A CRACK NEAR THE FILTER ON THE BAG SPIKE. THE CRACK WOULD CAUSE A LEAK DURING USE. THE PROBABLE CAUSE OF THE CRACK IS UNKNOWN. DEVICE HISTORY REVIE COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REQUESTED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED. D4: ONLY DI PROVIDED AS LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 41 CM (16") APPX 2.7ML, EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE¿, LUER CHECK VALVE AND IT WAS REPORTED THAT THE CYTOTOXIC DRUG LEAK WAS DETECTED IN THE OUTPATIENT CHEMOTHERAPY UNIT, AT THE PATIENT'S BEDSIDE. THE BAG AND ITS EXTENSION WERE QUICKLY ISOLATED, AND A CLEARLY VISIBLE CRACK WAS OBSERVED AT THE SPIKE OF THIS OPAQUE TUBING. THE CRACK WAS NOT PRESENT DURING BAG PREPARATION IN THE CHEMOTHERAPY UNIT, NOR AT THE TIME OF DISPENSING, AS NO LEAKAGE WAS OBSERVED AT THOSE TIMES. THE SPIKE THEREFORE CRACKED IN THE INTERVAL BETWEEN DISPENSING AND ADMINISTRATION. THIS PROBLEM OCCURRED TWICE, WITH TWO DIFFERENT PATIENTS, BUT WITH THE SAME PRODUCT: CYCLOPHOSPHAMIDE 1000 MG/2 ML REDDY PHARMA. CURRENT PATIENT CONDITION: NO ADVERSE PATIENT CONSEQUENCES, A FEW DROPS ON THE SKIN, IMMEDIATELY CLEANED WITH CLEAN WATER. CYTOTOXIC LEAK EXPOSING HEALTHCARE STAFF. ACTIONS TAKEN AT THE HEALTHCARE FACILITY FOR PATIENT MANAGEMENT: ISOLATION OF A DEFECTIVE MEDICAL DEVICE, CHANGE TO THE PROTOCOL FOR PREPARING THIS CYTOTOXIC AGENT: MULTIPLE RINSES ADDED TO THE PROCEDURE TO FURTHER DILUTE THE PRODUCT IN THE AREA WHERE THE UNDILUTED PRODUCT IS ADDED [NOTE: CYCLOPHOSPHAMIDE FROM THIS LAB WITH A CONCENTRATION OF 500 MG/ML VERSUS 20 MG/ML FOR BAXTER'S ENDOXAN]. THERE WAS REPORTED PATIENT INVOLVEMENT. THERE WAS ONLY ONE PATIENT WHO WAS EXPOSED TO THE SKIN LEVEL. THERE WAS APPROXIMATELY 45 MINUTES DELAY FOR THE PATIENT WHO HAD BEEN EXPOSED. THE THERAPIES WERE COMPLETED. THE LEAK WAS CLEANED UP ACCORDING TO THE FACILITY'S PROTOCOL WITH A SPECIFIC KIT. THE PATIENTS RECEIVED THE FULL PRESCRIBED DOSE. THIS REPORT IS FOR PATIENT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577 41 CM (16") APPX 2.7ML, EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE®, LUER CHECK STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CYCLOPHOSPHAMIDE 500 MG/ ML, REDDY PHARMA| ENDOXAN 20 MG/ML, BAXTER