BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 11193269 · Received January 19, 2021

    Report

    Report Number
    9617594-2021-00009
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    December 22, 2020
    Report Date
    December 22, 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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE A PROBABLE CAUSE IS UNABLE TO BE DETERMINED. A DEVICE HISTORY REVIEW FOR LOT# 4981626 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. CONCOMITANT PRODUCTS ARE AS FOLLOWS: CHEMOLOCK¿ BAG SPIKE WITH CLAVE¿ ADDITIVE PORT, LIST# CL3940, MFR ICU MEDICAL. UNSPEC TUBING SET, MFR BD. UNSPECIFIED CHEMO DRUG (MFR UNK).

    Description of Event or Problem · 1

    THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP. IT WAS REPORTED THAT THE NURSE PREPARED FOR ADMINISTRATION WITH BD TUBING AND THE SPIROS. UPON CIRCLE PRIMING THE SET, THE DISTAL END OF THE TUBING FELL OFF OF THE SPIROS AND THE LINE STARTED DRIPPING AN UNSPECIFIED CHEMOTHERAPY DRUG. THE MEDICATION WAS THEN REMADE AND NEW TUBING WAS USED. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91695 SPINNING SPIROS CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4981626 00840619026615

    Patients

    Seq Age Sex Outcome Treatment
    1