BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 11278888 · Received February 4, 2021

    Report

    Report Number
    9617594-2021-00030
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Date of Event
    January 13, 2021
    Report Date
    January 13, 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
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY REVIEW FOR LOT NUMBER 4131563 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP THAT DURING AMBULATORY INFUSION OF 5FU, A LEAK WAS NOTED AT AN UNSPECIFIED LOCATION. THE SET UP WAS A SPIROS WAS CONNECTED TO THE AMBULATORY LINE, THEN CONNECTED TO THE MICROCLAVE. THERE WAS NO BLOOD LOSS OR BLEED BACK, THE TUBING AND DRUG WAS NOT REPLACED AND THERAPY NOT RESUMED. THERE WAS NO HOLE, CUT, TEARS OR ANY DEFECT NOTED. THERE WAS PATIENT INVOLVEMENT, AND ALTHOUGH THERE WAS A REPORT OF A DELAY IN THERAPY, NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174615 SPINNING SPIROS CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4131563 00840619026615

    Patients

    Seq Age Sex Outcome Treatment
    1 5FU, MFR UNK| UNSPEC IV SET, MFR UNK| UNSPEC MICROCLAVE, MFR ICU MEDICAL