BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS® CLOSED MALE LUER, RED CAP

    MDR report key: 15199207 · Received August 10, 2022

    Report

    Report Number
    9617594-2022-00231
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    July 19, 2022
    Report Date
    July 20, 2022
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED. THE CUSTOMER IDENTIFIED A POSSIBLE OF 5 LOT NUMBERS (PLOT) OF; 5069556 (EXPIRY DATE 11/01/2025, MFR DATE 11/10/2020). 5803311 (EXPIRY DATE 01/01/2027, MFR DATE 02/02/2022). 5230102 (EXPIRY DATE 03/01/2026, MFR DATE 03/31/2021). 5558860 (EXPIRY DATE 08/01/2026, MFR DATE 08/23/2021. 5579719 (EXPIRY DATE 08/01/2026, MFR DATE 08/24/2021).

    Description of Event or Problem · 0

    THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, RED CAP. IT WAS REPORTED THAT THE DEVICE WAS DETACHED FROM THE PORT AND WAS LEAKING. THE EVENT OCCURRED DURING PATIENT USE AND THERE WAS UNPROTECTED CHEMO EXPOSURE TO THE PATIENT, BUT NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439605 SPINNING SPIROS® CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 20130-01 PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown FLUOROURACIL, MFR UNK