BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4252313 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40779
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    October 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K132734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A ONE-LINK CATHETER EXTENSION SET HAD AN UNSPECIFIED PROBLEM WITH ITS RETRACTABLE COLLAR. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVALUATION WAS COMPLETED TO INVESTIGATE THE REPORTED ISSUE. THE ACTUAL SAMPLE WAS NOT RETURNED FOR DEVICE EVALUATION; HOWEVER, A PHOTOGRAPH WAS RECEIVED. PHOTOGRAPHIC INSPECTION REVEALED THE LUER LOCKING ADAPTER SLEEVE HAD DISCONNECTED FROM THE LUER BODY. THEREFORE, THE REPORTED ISSUE WAS VERIFIED. THE CAUSE OF THE DISCONNECTION COULD NOT BE DETERMINED. THIS ISSUE IS CURRENTLY BEING ADDRESSED THROUGH A CAPA. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN CLEARLINK SET HAD AN UNSPECIFIED PROBLEM WITH ITS RETRACTABLE COLLAR. THE REPORTER STATED THAT THIS ISSUE RESULTED IN A LEAK. THIS OCCURRED WHILE THE PATIENT WAS CONNECTED FOR INFUSION OF AN UNSPECIFIED DRUG. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738683 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR14E19086

    Patients

    Seq Age Sex Outcome Treatment
    1