BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    40 CM (16") PUR AMBRATO SET LIN, PERF CON VALVOLA, Y-CLAVE®, FILTRO TAXOL E LL

    MDR report key: 19955898 · Received August 9, 2024

    Report

    Report Number
    9617594-2024-01118
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 1, 2024
    Report Date
    October 8, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619019853
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B: THE DATE OF EVENT IS UNKNOWN, 7/1/2024 HAS BEEN USED AS A PLACEHOLDER. SECTION D AND H: THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED. SECTION E INITIAL REPORTER (FULL) PHONE NUMBER: (B)(6).

    Additional Manufacturer Narrative · 0

    NO 011-H2589 PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DHR WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A PROBABLE CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED. ADDITIONAL INFORMATION CAN BE FOUND IN B5, D4, D9, E1 AND H4.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 40 CM (16") PUR AMBRATO SET LINEARE, PERFORATORE CON VALVOLA, Y-CLAVE®, FILTRO TAXOL E LL GIR EXPERIENCED LEAKAGE. THE FOLLOWING ISSUE WAS REPORTED BY THE CUSTOMER: ¿WE HAVE ENCOUNTERED SEVERAL CRITICAL ISSUES IN THE USE OF THE PIGTAILS SUPPLIED TO US (RESOLUTION 226/2022), MORE PRECISELY DRUG LEAKAGE DETECTED FROM THE 0.2 MICRON FILTER. TODAY IT WAS NECESSARY TO RE-PREPARE A THERAPY BECAUSE THE DRUG CAME OUT OF THE FILTER WITH CONSEQUENT DELAY IN ADMINISTERING IT TO THE PATIENT AS WELL AS CONTAMINATION OF THE WORK ENVIRONMENT". INCIDENT CLASS UNKNOWN. THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT IS UNKNOWN. THERE IS PATIENT INVOLVEMENT, BUT UNKNOWN HARM.

    Description of Event or Problem · 0

    THE CUSTOMER PROVIDED ADDITIONAL INFORMATION AS FOLLOWS: THE CHEMO SPILL WAS CLEANED UP ACCORDING TO THE PROTOCOL. THERE NO PHYSICAL DEFECT OBSERVED ON THE DEVICE. THE DRUG WAS REPLACED. NOBODY WAS INJURED OR DEAD. THIS EVENT LED TO A DELAY IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200393 40 CM (16") PUR AMBRATO SET LIN, PERF CON VALVOLA, Y-CLAVE®, FILTRO TAXOL E LL STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13543785 00840619019853

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNSPECIFIED DRUG , MFR UNK.