BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMOCLAVE® VENTED BAG SPIKE

    MDR report key: 20361294 · Received October 3, 2024

    Report

    Report Number
    9617594-2024-01378
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    August 27, 2024
    Report Date
    October 3, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619023751
    PMA / PMN Number
    K173477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) USED. LIST #CH-14, CHEMOCLAVE® CONNECTED TO SALINE INJECTION 0.9% SODIUM CHLORIDE 0.9% 500ML IV BAG WERE RETURNED FOR EVALUATION. AS RETURNED NO PHYSICAL DAMAGE OR ANOMALIES WERE OBSERVED ON THE RETURNED SAMPLE. THE RETURNED SET WAS TESTED NO FLOW WAS CONFIRMED. THE CLAVE WAS DISSEMBLED AND NO DAMAGES OR ANOMALIES WERE OBSERVED. THE SAMPLE WAS CUT AND ERRANT SOLVENT WAS FOUND IN THE FLUID PATH. COMPLAINT OF SOLUTION COULDN'T DRIP CAN BE CONFIRMED. THE PROBABLE CAUSE IS DUE TO AN ERRANT SOLVENT DURING ASSEMBLY PROCESS IN MANUFACTURING. LOT HISTORY REVIEW WAS PERFORMED AND NO RELEVANT DISCREPANCY, ANOMALIES OR NONCONFORMANCE WERE IDENTIFIED THAT MIGHT LEAD THE CONDITION REPORTED BY THE CUSTOMER. ADDITIONAL CONTACT INFORMATION: EVERMEDICAL CO., LTD. SILVIA LIN [email protected] 886-2-2712-6611.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A CHEMOCLAVE® VENTED BAG SPIKE WHERE THE CUSTOMER REPORTED A NO FLOW ISSUE; THE SOLUTION (NORMAL SALINE) COULD NOT DRIP. SE FOR CHEMO. DEVICE WAS NOT BIOHAZARD. THE EVENT AS NOTED DURING INFUSION OF NORMAL SALINE. UNKNOWN IF THERE WAS USER FACILITY MEDWATCH. THERE WAS NO BLEED BACK. DEVICE WAS NOT REPROCESSED OR RE-STERILIZED. THERE WAS PATIENT INVOLVEMENT, HOWEVER HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040699 CHEMOCLAVE® VENTED BAG SPIKE SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13895850 00840619023751

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NORMAL SALINE, MFR UNK