BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE CONNECTOR

    MDR report key: 2879546 · Received December 14, 2012

    Report

    Report Number
    2025816-2012-00051
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 14, 2012
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: IN THE ABSENCE OF TESTING THE INVOLVED DEVICES THE EXACT CAUSE(S) OF THIS EVENT ARE UNK AT THIS TIME. THIS REPORT AND THE ASSOCIATED INFO HAVE BEEN ENTERED IN THE MFR'S DATABASE FOR MONITORING AND TRENDING.

    Description of Event or Problem · 1

    (B)(4) REPORT REC'D. CONCERNING OCCLUSION PROBLEM WITH ONE (1) 11956 CLAVE CONNECTOR. THE REPORT STATES "PT RECEIVING IV MEDICATION FOR SEDATION AND ANALGESIA. MEDICATIONS NOT EFFECTIVE... PT REQUIRED ADDITIONAL DOSES WITHOUT EFFECT. UPON EXAM OF THE CLAVE, IT WAS FOUND THAT CLAVE WAS PERMANENTLY DEPRESSED, PREVENTING THE MEDICATION FROM INFUSING.". THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. ALTHOUGH REQUESTED, THE INVOLVED 11956 CLAVE CONNECTOR WAS NOT RETURNED TO THE MFR FOR INVESTIGATION AND CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVE CONNECTOR NEEDLELESS CONNECTOR FPA ICU MEDICAL, INC. 11956 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO IV ADMINISTRATION DEVICES