BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE NEEDLELESS CONNECTOR

    MDR report key: 28403 · Received December 1, 1995

    Report

    Report Number
    MW1007819
    Event Type
    Malfunction
    Date Received
    December 1, 1995
    Date of Event
    November 21, 1995
    Report Date
    November 21, 1995
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ICU MEDICAL, INC. 951 CALLE AMANECER, SAN CLEMENTE, CA 92673. SUBSEQUENT TO OUR RESPONSE TO THE FDA, AND AFTER FURTHER DISCUSSIONS WITH THE USER, IT APPEARS THAT THE USER'S ISSUE IS RELATED TO CRACKING OF THE FEMALE LUER ON AN EXTENSION SET NOT MFG BY ICU MEDICAL. I TOLD THE USER, OPTION CARE, THAT WE WILL INVESTIGATE TO DETERMINE THE CONNECTION, IF ANY, BETWEEN FEMALE LUER EXTENSION SET CRACKING AND THE CLAVE CONNECTOR. THE USER WAS LASO ADVISED TO CONTACT THE EXTENSION SET MFR. IT IS EXPECTED THAT OUR INVESTIGATION WILL BE CONCLUDED SHORTLY AND WE WILL SEND YOU THIS ADD'L INFO NO LATER THAN 2/15/96. AT THIS TIME THIS IS NOT CONSIDERED A MEDICAL DEVICE REPORT (MDR) EVENT. WE HAVE OPENED A COMPLAINT FILE TO TRACK THE INVESTIGATION. OUR REF NUMBER IS 51112 AND 51113.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other