BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 11269873 · Received February 2, 2021

    Report

    Report Number
    9617594-2021-00024
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Date of Event
    January 10, 2021
    Report Date
    January 11, 2021
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619026615
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY REVIEW FOR LOT NUMBER 5000437 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE REPORTED COMPLAINT CANNOT BE CONFIRMED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED. ADDITIONAL INFORMATION CAN BE FOUND IN SECTION D9.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED FOR EVALUATION, BUT HAS YET TO BE RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP THAT LEAKED CHEMOTHERAPY WHEN THE SPIROS DISCONNECTED FROM THE PUMP TUBING. THE LEAK WAS NOTICED ON THE PATIENT¿S SHEETS AFTER 200ML OF ETOPOSIDE WAS INFUSED. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE OUTCOME WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164664 SPINNING SPIROS CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5000437 00840619026615

    Patients

    Seq Age Sex Outcome Treatment
    1 ETOPOSIDE, MFR UNK| UNSPECIFIED TUBING, BD MFR