BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14" (36 CM) APPX 4.3 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS® W/RED CAP, 2 CLA

    MDR report key: 23639143 · Received November 24, 2025

    Report

    Report Number
    9617594-2025-02212
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    November 10, 2025
    Report Date
    December 30, 2025
    Manufacturer
    .
    Product Code
    ONB
    UDI-DI
    00887709086883
    PMA / PMN Number
    K173477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE FOR EVALUATION- IT HAS NOT BEEN RECEIVED. THE INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 0

    ONE USED SAMPLE CONNECTED TO AN UNKNOWN, INFUSION SET WERE RETURNED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WAS CONDUCTED. AS RECEIVED, NO PHYSICAL DAMAGE ONLY ONE OF THE SPIROS WAS NOT PROPERLY CONNECTED WITH THE UNKNOWN INFUSION SET, THIS HAPPENED BECAUSE THE SPINNING MECHANICS WAS ALREADY ACTIVATED, MAKING NOT POSSIBLE TO CONNECT WITH THE THREADS OF THE MATING DEVICE. THE SHEAR TAB WAS ACTIVATED CORRECTLY AND NO DAMAGE ON THE SPLINES WERE OBSERVED. THE SET WAS TESTED AS RECEIVED AND NO LEAKS WERE NOTED. THE TORQUE RESIDUAL WAS FOUND WITHIN SPECIFICATION. THE FEMALE AND MALE LUER MET ISO COMPLAINT SPECIFICATION. AS RECEIVED, THE ICU MEDICAL WAS FUNCTIONAL TESTED AND NO LEAKS OR DISCONNECTIONS WERE NOTED. HOWEVER, THE UNKNOWN INFUSION SET WAS NOT PROPERLY ENGAGED. THE REPORTED EVENT WAS NOT CONFIRMED, AND THE PROBABLE CAUSE IS UNABLE TO BE DETERMINED. D9: DATE RETURNED TO MFG.: 12/1/2025.

    Description of Event or Problem · 0

    EVENT OCCURRED REGARDING TO 14" (36 CM) APPX 4.3 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS W/RED CAP, 2 CLAMPS (BLUE, RED), VENTED CAP, DROP-IN SPIROS W/RED CAP WHERE IT WAS REPORTED THAT THE SPIROS THAT ATTACHED TO THE BIFUSE (NOT THE SPINNING ONE AT THE BOTTOM), CAME PARTIALLY DETACHED AND WAS ABLE TO MOVE UP AND DOWN ON THE TUBING WHEN IT¿S USUALLY FIXED IN PLACE. THEY ALSO REPORTED CHEMO LEAKED DUE TO THIS SEPARATION. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM AND THERE WAS DELAY IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294119 14" (36 CM) APPX 4.3 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS® W/RED CAP, 2 CLA CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB . UNKNOWN 00887709086883

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown