BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLELESS CONNECTOR W/ EXTENS

    MDR report key: 5790256 · Received July 13, 2016

    Report

    Report Number
    1282497-2016-00482
    Event Type
    Malfunction
    Date Received
    July 13, 2016
    Date of Event
    June 15, 2016
    Report Date
    June 15, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 7/13/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 8/25/16. THERE WERE NO SAMPLES RECEIVED WITH THIS COMPLAINT THEREFORE AN EXAMINATION OF THE DEFECT COULD NOT BE MADE. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT PERFORMED DURING THIS INVESTIGATION AS THE LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY PRIOR TO RELEASE OF PRODUCT. BECAUSE THERE WAS NO LOT NUMBER, A DATE OF MANUFACTURE COULD NOT BE DETERMINED. A POTENTIAL ROOT CAUSE IS THAT THE CONNECTION WAS NOT VERIFIED TO BE SECURE BEFORE USE. THE INSTRUCTIONS FOR USE STATE THAT THIS PRODUCT MUST BE INSPECTED PRIOR TO USE. SINCE THIS COMPLAINT WILL BE CONSIDERED AS UNCONFIRMED, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. IF ADDITIONAL INFORMATION OR SAMPLES ARE RECEIVED, THE INVESTIGATION WILL RESUME AS NEEDED. THIS COMPLAINT WILL BE USED FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS KNC (KENDALL NEEDLESS CONNECTOR) WAS NOT PROPERLY SCREWED ON TO AN IV EXTENSION SET WHICH CAUSE HEPARIN TO CONTINUE TO DRIP. ADDITIONAL DOSES WERE GIVEN (TOTAL OF SIX DOSES) BEFORE IT WAS NOTED A PUDDLE OF BLOOD WAS ON THE FLOOR WHERE THE EXTENSION SET AND THE CONNECTOR BECAME DISCONNECTED. A PATIENT IN CATH LAB WAS REQUIRING REGULAR DOSES OF IV HEPARIN FOR ANTICOAGULATION DURING THE PROCEDURE. THE CARDIOLOGIST AN ANESTHESIOLOGIST NOTED THAT THE EXPECTED RESPONSE WAS NOT BEING ACHIEVED. ADDITIONAL DOSES WERE GIVEN (TOTAL OF SIX DOSES) BEFORE IT WAS NOTED A PUDDLE OF BLOOD WAS ON THE FLOOR WHERE THE EXTENSION SET AND THE CONNECTOR BECAME DISCONNECTED. ONCE A SECURE CONNECTION WAS OBTAINED, THE PATIENT'S DESIRED COAGULATION STATUS WAS ACHIEVED. NO ADVERSE OUTCOME OCCURRED AS THE ERROR WAS DISCOVERED QUICKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442709 NEEDLELESS CONNECTOR W/ EXTENS NEEDLESS CONNECTOR SET WITH EXTENSION FPA COVIDIEN 2000NP

    Patients

    Seq Age Sex Outcome Treatment
    1