BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED BAG SPIKE, CLAVE®, 25 UNITS

    MDR report key: 20683556 · Received November 14, 2024

    Report

    Report Number
    9617594-2024-01600
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 11, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619060749
    PMA / PMN Number
    K082836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE (1) USED UNIT. LIST #CH-14-25, VENTED BAG SPIKE, CLAVE®, 25 UNITS; LOT #13745157. --> ONE (1) USED. LIST #UNKNOWN, FRESENIUS KABI GLUCOSE 5% FREEFLEX 250 ML INTRAVENOUS BAG; LOT #13SLF292. ONE (1) USED UNIT. LIST #CH-14-25, VENTED BAG SPIKE, CLAVE®, 25 UNITS; LOT #13745157. --> ONE (1) USED. REF #(B)(4), BAXTER EXACTAMIX 250 ML EVA INTRAVENOUS BAG; LOT #N22-0370. TWO (2) USED. LIST #UNKNOWN, CLAVE VENTED SPIKE; LOT #UNKNOWN. --> TWO (2) USED. LIST #UNKNOWN, FRESENIUS KABI PACLITAXEL 300 MG VIAL; LOT #87230489AB. NO VISUAL DAMAGES OR ANOMALIES WERE OBSERVED. THE REPORTED COMPLAINT OF FLOATERS IN THE BAG COULD BE CONFIRMED. THERE WERE FLOATERS IN THE EXACTAMIX BAG AND NO FLOATERS IN THE GLUCOSE BAG OR IN EITHER OF THE VIALS RECEIVED. THE FLOATERS WERE OBSERVED UNDER A MICROSCOPE AND WERE OBSERVED TO BE SOFT AND NOT A HARD PLASTIC. THE SOURCE OF THE FLOATERS IS UNKNOWN. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    E1 - INITIAL REPORTER PHONE (B)(6). THE DEVICE WAS RECEIVED FOR EVALUATION. THE INVESTIGATION IS PENDING.

    Description of Event or Problem · 0

    A COMPLAINT INVOLVING A VENTED BAG SPIKE, CLAVE®, 25 UNITS EXPERIENCED PARTICULATE IN THE FLUID PATH. THE REPORTER STATED THAT, THE PROBLEM OCCURRED ON (B)(6) 2024 WITH THE DRUG ABRAXANE NABPACLITAXEL WHEN THEY WERE MAKING UP THE DRUG USING CH14 BAG SPIKE & A CODE E3002-OD EVABAG A FLOATER NOTICED IN THE BAG. THEY HAVE THE CYTOTOXIC SAMPLE INVOLVED WHICH WE WILL SEND TO ICU MEDICAL FOR INVESTIGATION. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS BEFORE USE. THE IDENTITY OF INVOLVED AND/OR MATING DEVICES WAS EVA 250 ML BAG FROM (BAXTER), CODE E3002-OD EVABAG EXACTAMIX REF LOT N22-0370 AND CH14 BAG SPIKE IN THE ABRAXANE CHEMO DRUG. THE TYPE OF PROCEDURE WAS ASEPTIC PHARMACY DEPT COMPOUNDING UNIT MEDICATIONS¿ CHEMOTHERAPY. THE PROBLEM WAS DETECTED PRIOR TO DIRECT PATIENT USE. THERE WAS NO SERIOUS INJURY, NO BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE, NO ADVERSE OPERATOR CONSEQUENCES AND NO MED/SURG INTERVENTION REQUIRED. INVOLVED DEVICE IS AVAILABLE TO BE TESTED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205690 VENTED BAG SPIKE, CLAVE®, 25 UNITS STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13745157 00840619060749

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CH14 BAG SPIKE IN THE ABRAXANE CHEMO DRUG.| E3002-OD EVABAG EXACTAMIX REF LOT N22-0370.| EVA 250 ML BAG FROM (BAXTER ).