BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 10635836 · Received October 6, 2020

    Report

    Report Number
    9617594-2020-00430
    Event Type
    Malfunction
    Date Received
    October 6, 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
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H10: NO PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY REVIEW FOR LOT 4896004 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 RETURN OF THE SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SPINNING SPIROS CLOSED MALE LUER, RED CAP THAT WHEN APPLIED ON THE SYRINGE CONTAINING THE DRUG TO BE ADMINISTERED, AFTER THE CONNECTION TO THE NEEDLESS, AT THE TIME OF ASPIRATION (PERFORMED TO CHECK THE BLOOD RETURN) THE SYRINGE HAS DRAWN AIR INTO IT. AT THE TIME OF THE INJECTION, THE DRUG LEAKED FROM THE SPIROS, WETTING THE PATIENT'S SKIN AND CAUSING ENVIRONMENTAL CONTAMINATION. THE DRUG TO BE ADMINISTERED WAS DOXORUBICIN. THE CONSEQUENCES OF THE EVENT WAS THE DECONTAMINATION OF THE PATIENT AND OF THE ENVIRONMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103906 SPINNING SPIROS CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4896004 00840619026615

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR DOXORUBICIN, MFR UNK| UNSP SYRINGE, UNK MFR| DOXORUBICIN, MFR UNK| UNSP SYRINGE, UNK MFR