BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2963755 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03929
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K123868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT DATE THAT THE EVENT OCCURRED IS UNKNOWN. THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS VISUALLY AND MICROSCOPICALLY INSPECTED DURING PRODUCT EVALUATION. THE REPORTED CONDITION WAS CONFIRMED DURING EVALUATION, AS A LEAK THAT WAS FOUND NEAR THE CENTER Y SITE. HOWEVER, THE CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    BAXTER SALES REPRESENTATIVE (BSR) NOTIFIED BAXTER CORPORATE PRODUCT SURVEILLANCE (CPS) OF ONE INTERLINK(TM)CONTINU-FLO SOLNSET 3INJ SITES 10DPM IN WHICH A LEAK WAS OBSERVED. IT WAS REPORTED THAT THE SET "SPRAYED." THE SET WAS INFUSING PROPOFOL INTO A PATIENT BY AN ANESTHESIOLOGIST. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68122 ACCESS ADMINISTRATION, SET, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 PROPOFOL