BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE CLEAR, CHEMOLOCK PORT, SPIROS

    MDR report key: 10454799 · Received August 26, 2020

    Report

    Report Number
    9617594-2020-00346
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 31, 2020
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00887709077201
    PMA / PMN Number
    K131549
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY REVIEW FOR LOT NUMBER 4172961 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.

    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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A MEDSUN MANDATORY MEDWATCH REPORT WAS RECEIVED THAT STATED ¿THE RN CONNECTED A CHEMOTHERAPY LINE TO A PATIENT, AND LINE WAS FLUSHED MANUALLY. RN TIGHTENED ALL THE CONNECTIONS AND THE LINE WAS DOUBLE CHECKED PRIOR TO STARTING CHEMOTHERAPY. IMMEDIATELY UPON STARTING THE CHEMOTHERAPY, THE PATIENT REPORTED FEELING MOISTURE. THERE WAS A LEAK ON THE IV MICROCLAVE CLEAR WITH CHEMOLOCK CONNECTOR.¿ THE EVENT OCCURRED ON AN UNSPECIFIED DAY IN (B)(6) 2020 AND HAPPENED IN THE PATIENT¿S ROOM OF THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO REPORT OF ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919962 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE CLEAR, CHEMOLOCK PORT, SPIROS CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CL3931 4172961 00887709077201

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR UNSPECIFIED CHEMOTHERAPY DRUG, MFR UNK| UNSPECIFIED CHEMOTHERAPY DRUG, MFR UNK