BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP

    MDR report key: 8672161 · Received June 5, 2019

    Report

    Report Number
    9617594-2019-00163
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    May 9, 2019
    Report Date
    May 21, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DISCARDED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED WITHOUT THE RETURNED SAMPLE. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER IDENTIFIED SEVEN POSSIBLE LOT NUMBERS (PLOTS). THE POSSIBLE LOT NUMBERS ARE 3553926 (EXPIRY DATE 11/01/2022 , MFR DATE 11/01/2017), 3905536 (EXPIRY DATE 12/01/2023, MFR DATE 12/01/2018), 3803605 (EXPIRY DATE 10/01/2023, MFR DATE 10/01/2018), 3520162 (EXPIRY DATE 08/01/2022, MFR DATE 08/01/2017), 3972775 (EXPIRY DATE 02/01/2024, MFR DATE 02/01/2019), 3653544 (EXPIRY DATE 04/01/2023, MFR DATE 04/01/2018) AND 3667618 (EXPIRY DATE 05/01/2023, MFR DATE 05/01/2018). THE DEVICE HISTORY REVIEW (DHR) FOR LOTS 3553926, 3905536, 3803605, 3520162, 3972775, 3653544 AND 3667618 WERE REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCE'S FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP, THAT DURING THE ADMINISTRATION OF EPIRUBICIN, ¾ OF THE MEDICATION HAD BEEN ADMINISTERED WHEN A LEAKAGE WAS OBSERVED AT THE LEVEL OF THE SPIROS (APPROXIMATELY 6 ML). THE TOTAL AMOUNT OF EPIRUBICIN WAS NOT ADMINISTERED. THE PATIENT WAS RECEIVING CHEMOTHERAPY VIA AN IMPLANTABLE INJECTION CHAMBER TO TREAT BREAST CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463712 SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR