BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15 CM (6") APPX 0.35 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMP

    MDR report key: 9616011 · Received January 22, 2020

    Report

    Report Number
    9617594-2020-00019
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Date of Event
    December 1, 2019
    Report Date
    December 31, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619058630
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY REVIEW (DHR) FOR LOT NUMBER 4022836 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A PROBABLE CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED SMALLBORE BI-FUSE EXT SET W/ 2 CLAVE®, ROTATING LUERS THAT WERE REPORTED TO LEAK FROM THE FREE/UNCONNECTED LUMEN DURING INFUSIONS OF CHEMOTHERAPY. THE DEVICES WERE CHANGED REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS REPORT OF UNPROTECTED CHEMO EXPOSURE, AND UNSPECIFIED ADVERSE OPERATOR CONSEQUENCES, HOWEVER, THERE WAS NO PATIENT HARM REPORTED, AND NO MEDICAL/SURGICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80634 15 CM (6") APPX 0.35 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMP STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4022836 00840619058630

    Patients

    Seq Age Sex Outcome Treatment
    1