BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 10669541 · Received October 13, 2020

    Report

    Report Number
    9617594-2020-00441
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    September 24, 2020
    Report Date
    September 25, 2020
    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
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: NO PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY REVIEW (DHR) FOR LOT 4895446 WAS REVIEWED AND A POPPET SUB-COMPONENT WAS FOUND THAT HAD A MOLDING ANOMALY ON THE SEALING SURFACE THAT CAN LEAD TO LEAKAGE. THE REPORTED COMPLAINT OF A LEAKING SPIROS CAN BE CONFIRMED. THE PROBABLE CAUSE OF THE LEAKING SPIROS IS DUE TO A MOLDING ANOMALY ON THE SEALING SURFACE OF THE POPPET SUB-COMPONENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE RETURNED DEVICE THE PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SPINNING SPIROS CLOSED MALE LUER, RED CAP THAT WAS APPLIED TO A SYRINGE CONTAINING DOXORUBICIN TO BE ADMINISTERED. AFTER THE CONNECTION, AT THE TIME OF ASPIRATION TO CHECK FOR BLOOD RETURN, THE SYRINGE HAD DRAWN AIR INTO IT. AT THE TIME OF INJECTION, THE DRUG LEAKED FROM THE DEVICE, WETTING THE PATIENT¿S SKIN AND CAUSING ENVIRONMENTAL CONTAMINATION. THERE WAS PATIENT INVOLVEMENT AND THE CONSEQUENCES OF THE EVENT WAS DECONTAMINATION OF THE PATIENT AND THE ENVIRONMENT, HOWEVER, NO REPORT OF ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136732 SPINNING SPIROS CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4895446 00840619026615

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR DOXORUBICIN, MFR UNK| UNSPECIFIED SYRINGE, MFR UNK