BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE® CLEAR NEUTRAL CONNECTOR

    MDR report key: 20320923 · Received September 27, 2024

    Report

    Report Number
    9617594-2024-01359
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 30, 2024
    Report Date
    December 19, 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

    THE DEVICE IS AVAILABLE FOR EVALUATION. THE INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 0

    NO MC100 PRODUCT SAMPLES, VIDEOS OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DHR WAS REVIEWED AND THERE WERE NO 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. THE DEVICE HISTORY REVIEW (DHR) FOR LOT NUMBER 5960803 WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A MICROCLAVE® CLEAR NEUTRAL CONNECTOR WHERE THE REPORTER STATED THAT THE LIPIDS BACKED UP INTO MEDLINE AND CREATED PUDDLE ON THE FLOOR FROM MICROCLAVE CONNECTION. THEY CHANGED MICROCLAVE THREE TIMES AND THE MEDICATION CONTINUED TO LEAK. IT WAS ALSO STATED THAT THEY DISCARDED MICROCLAVE AND ATTACHED MED SYRINGE DIRECTLY TO MEDLINE TUBING AND NO LEAKING WAS OBSERVED. HOWEVER, THERE WAS A POTENTIAL RISK OF INFECTION FOR PICC LINE. 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
    1610940 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 LIPIDS, MFR UNK| PERIPHERALLY INSERTED CENTRAL CATHETER, MFR UNK| SYRINGE, MFR UNK| TUBING, MEDLINE