BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE CONNECTOR

    MDR report key: 3854016 · Received April 28, 2014

    Report

    Report Number
    2025816-2014-00046
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    January 28, 2014
    Report Date
    January 28, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURERS INVESTIGATION: A TWO YEAR REVIEW OF THE COMPLAINT DATABASE FOR MICROCLAVE CLEAR CONNECTORS - GENERAL LEAKAGE DID RECORD ADDITIONAL REPORTS AND INVESTIGATIONS. A REVIEW OF THOSE INVESTIGATION RECORDED MIXED FINDINGS INCLUDING USAGE ERRORS; INCOMPATIBLE MATING/ACCESS DEVICES; NO DEFECT FOUND; CANNOT DETERMINE AND MFG/DESIGN. FINDINGS: THE INVOLVED DEVICES WERE NOT RETURNED FOR ANALYSIS AND INVESTIGATION. THE EXACT CAUSE(S) OF THE REPORTED PRODUCT EXPERIENCES/ISSUES ARE UNK.

    Description of Event or Problem · 1

    MAUDE EVENT REPORT MW5034126 RECEIVED REPORTING A (B)(6) 2014 INCIDENT INVOLVING USE OF ONE MICROCLAVE CLEAR CONNECTOR. THE REPORT STATES "CLEAR MICROCLAVE FOR NEONATE CENTRAL CATHETER FOUND LEAKING. CATHETER OCCLUDED SECONDARY TO LEAK, REQUIRING REPLACEMENT OF CENTRAL CATHETER". IT IS THE MANUFACTURERS UNDERSTANDING THAT THERE WERE NO ADVERSE PT CONSEQUENCES. THE MAUDE REPORT DOES NOT IDENTIFY COMPLAINANT, FACILITY, CONTACT INFO, IDENTIFY OF LIST # FOR THE INVOLVED CATHETER MATING AND ACCESS DEVICES, WHAT SET-UPS WERE IN PLACE, IDENTITY OF MEDICATIONS/INFUSION TREATMENTS OR ANY RELEVANT INFO FOR WHICH TO ASSESS THE EVENT AND PRODUCT ISSUE. A TWO YEAR REVIEW OF THE COMPLAINT DATABASE FOR MICROCLAVE CLEAR CONNECTORS - GENERAL LEAKAGE DID RECORD ADDITIONAL REPORTS AND INVESTIGATIONS. A REVIEW OF THOSE INVESTIGATION RECORDED MIXED FINDINGS INCLUDING USAGE ERRORS; INCOMPATIBLE MATING/ACCESS DEVICES; NO DEFECT FOUND; CANNOT DETERMINE AND MFG/DESIGN. FINDINGS: THE EXACT CAUSE(S) OF THE REPORTED EVENT AND PRODUCT EXPERIENCES/ISSUES ARE AT THIS TIME UNK. REFERENCE US/IMPORTER REPORT # MW5034126.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253949 MICROCLAVE CONNECTOR MICROCLAVE CONNECTOR FPA ICU MEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI NO INFORMATION