BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE® CLEAR NEUTRAL CONNECTOR

    MDR report key: 20320541 · Received September 27, 2024

    Report

    Report Number
    9617594-2024-01352
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 30, 2024
    Report Date
    November 10, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00887709037151
    PMA / PMN Number
    K100434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED LIST #MC100, MICROCLAVE¿ CLEAR NEUTRAL CONNECTOR: LOT #5960803. SOME LEAK RESIDUE WAS OBSERVED IN THE MICROCLAVE. THE REPORTED COMPLAINT OF A LEAK COULD BE CONFIRMED. THE PROBABLE CAUSE OF THE LEAK IS INCONSISTENT LUBRICATION DURING THE MANUFACTURING ASSEMBLY PROCESS. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. THE INVESTIGATION IS PENDING.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A MICROCLAVE® CLEAR NEUTRAL CONNECTOR WHERE THE REPORTER STATED THAT THE SEIZURE MEDICATION LEAKED FROM DISTAL MEDLINE CONNECTION BETWEEN TUBING AND MICROCLAVE. THE EVENT OCCURRED AT 9:50 AM DURING USE ON PATIENT. THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM OR ADVERSE EVENT AND UNKNOWN DELAY IN THERAPY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831320 MICROCLAVE® CLEAR NEUTRAL CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5960803 00887709037151

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TUBING, MEDLINE.| UNSPECIFIED SEIZURE MEDICATION, MFR UNK.