BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE® CLEAR NEUTRAL CONNECTOR

    MDR report key: 19177077 · Received April 24, 2024

    Report

    Report Number
    9617594-2024-00497
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    March 1, 2024
    Report Date
    June 18, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PHONE # FROM E1 IS (B)(6). THE DEVICE IS AVAILABLE FOR EVALUATION- IT HAS NOT BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF LEAKS ON ITEM MC100 CANNOT BE CONFIRMED. SINCE NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND PROBABLE CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY REPORT (DHR) FOR LOT#: 5960803 WAS REVIEWED AND NO NON-CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED CONDITION ON THE COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A MICROCLAVE® CLEAR NEUTRAL CONNECTOR WHERE THE CUSTOMER REPORTED THAT THE PATIENT'S PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE CLOTTED AND HAD TO BE REMOVED BECAUSE THE HEPARIN INFUSION WAS LEAKING. THE NURSE NOTICED THE LINE WAS LEAKING SHORTLY AFTER SETTING UP THE LINES. THE NURSE ADDED CLAVES TO DETERMINE IF THAT WOULD REMEDY THE PROBLEM; HOWEVER, THE LEAKING CONTINUED. THE NURSE THEN CHANGED ALL OF THE CLAVES, BUT THAT DID NOT SOLVE THE ISSUE. EVENTUALLY, THE NURSE HAD TO CHANGE THE ENTIRE LINE SETUP. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502279 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 HEPARIN, MFR UNK.| PERIPHERALLY INSERTED CENTRAL CATHETER, MFR UNK.