BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE CONNECTOR

    MDR report key: 3821245 · Received April 28, 2014

    Report

    Report Number
    2025816-2014-00049
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    February 1, 2014
    Report Date
    March 20, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A TWO YEAR REVIEW OF THE COMPLAINT DATABASE FOR 11956/ATTACHMENT ISSUES DID RECORD ADDITIONAL REPORTS/INVESTIGATIONS. A REVIEW OF THOSE DEVICE RETURN INVESTIGATIONS IDENTIFIED MIXED FINDINGS INCLUDING USAGE/ERRORS; NO DEFECT FOUND; UNK. THERE WERE NO FINDINGS THAT IDENTIFIED/VERIFIED A CONTRIBUTING MFG./DESIGN RELATED NON-CONFORMANCE. FINDINGS: THE INVOLVED DEVICES/SET-UPS WERE NOT RETURNED FOR ANALYSIS AND VERIFICATION. ALTHOUGH THE EXACT CAUSE(S) OF THE REPORTED PRODUCT EXPERIENCES/ISSUE ARE UNK, SITE VISIT/IN-SERVICING WITH STAFF DID IDENTIFY TECHNIQUE/USAGE CONDITIONS MOST LIKELY CONTRIBUTED TO THE REPORTED PRODUCT ISSUES.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING ATTACHMENT/LEAKAGE CONCERNS WITH USE OF 11956 CLAVE CONNECTORS AND CADD PUMP TUBING AND UNK MATING/ACCESS DEVICES. IT WAS REPORTED THAT "..OUTPATIENT CHEMOTHERAPY PRACTICE RECENTLY STARTED USING THE BLUE CLAVE WITH THEIR AMBULATORY INFUSION CADD PUMPS. ..HAVE HAD THREE INSTANCES IN APPROX 2-3 WEEKS WHERE THE CLAVE HAS COME LOOSE RESULTING IN AN OPEN IV LINE, BLEEDING, AND AN OPEN LINE OF HAZARDOUS MEDICATIONS..." THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. ADDITIONAL INCIDENT AND USAGE INFO INCLUDING STATUS OF DEVICE/SET-UP RETURNS HAS BEEN REQUESTED. AS OF THE DATE OF THIS REPORT THERE HAS BEEN NO RESPONSE. MFRS INVESTIGATION: THE PRODUCT ACCOUNT MANAGER MET WITH THE INVOLVED CLINICIANS TO OBSERVE THEIR USAGE/TECHNIQUES WITH "..ATTACHING THE CLAVE TO THE CADD PUMP TUBING. IT WAS OBSERVED THAT THEY WERE NOT ENGAGING/MATING THE COMPONENTS CORRECTLY.. IN-SERVICING WAS PERFORMED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254454 CLAVE CONNECTOR CLAVE CONENCTOR FPA ICU MEDICAL, INC. 11956 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI CADD PUMP TUBING