BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE CONNECTOR

    MDR report key: 2879530 · Received December 14, 2012

    Report

    Report Number
    2025816-2012-00052
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 28, 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 A (B)(6) 2012 LEAKAGE INCIDENT WITH USE OF ONE (1) 11956 CLAVE CONNECTOR, IV TUBING AND CENTRAL LINE (MFR MAKE AND MODEL UNK). THE REPORT STATES "PT RECEIVING SEDATION AND ANALGESIA MEDS VIA CENTRAL LINE (CLAVE CONNECTORS ON EACH PORT). PT AWAKE AND UNCOMFORTABLE, AREA DAMP TO TOUCH, MEDICATIONS NOTED TO BE INFUSING OUT SIDE OF CLAVE CONNECTOR. CLAVE REMOVED SITE FLUSHED, NEW CLAVAE APPLIED." THERE WERE NO REPORTED ADVERSE PT OUTCOME. ALTHOUGH REQUESTED ADDITIONAL RELEVANT EVENT INFO INCLUDING SET-UP, USAGE AND MATING DEVICES HAS NOT BEEN RECEIVED. 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 7 MO IV ADMINISTRATION DEVICES