BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP

    MDR report key: 8655979 · Received May 30, 2019

    Report

    Report Number
    9617594-2019-00151
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    May 8, 2019
    Report Date
    May 9, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THREE USED LIST # CH2000S-PC, SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP; SUSPECTED LOT #S 3972031 AND 3963910 WERE RECEIVED FOR EVALUATION. EACH OF THE USED CH2000S-PC SPINNING SPIROS ATTACHED TO VARIOUS SYRINGES WERE FUNCTIONALLY TESTED AS RETURNED. NO LEAKAGE WAS OBSERVED AT ANY CONNECTION OR LOCATION WITHIN THE CH2000S-PC SPINNING SPIROS ASSEMBLY. EACH OF THE USED CH2000S-PC SPINNING SPIROS WERE PRESSURE LEAK TESTED AND EACH PRESSURE LEAK EXPECTATIONS OUTLINED IN THE PRODUCT PERFORMANCE SPECIFICATION. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE SUSPECTED LOT #S 3972031 AND 3963910 WERE REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR TESTING AND INVESTIGATION; HOWEVER, THE INVESTIGATION IS NOT COMPLETE. PLOTS: SUSPECTED LOT NUMBERS: 3972031 (EXPIRY DATE 2024-02-01, MFR DATE 2019-02-01) AND 3963910 (EXPIRY DATE 2024-01-01; MFR DATE 2019-01-01).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT UPON CONNECTION OF TWO SPIROS CONNECTORS, THERE WAS VISIBLE MEDICATION OUTSIDE OF THE INTERNAL TUBE OF THE DEVICE. THE SPIROS WAS CONNECTED TO AN UNSPECIFIED VIAL ADAPTER. THERE WAS NO ADVERSE EVENT OR MEDICAL INTERVENTION REQUIRED, HOWEVER, UNPROTECTED CHEMO EXPOSURE WAS REPORTED. THIS REPORT CAPTURES 1 OF 2 SPIROS INVOLVED IN THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449729 SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP MALE LUER ADAPTER AND NEEDLELESS VALVE CONNECTOR (NEUTRAL PRESSURE) FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1