BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2061095 · Received April 18, 2011

    Report

    Report Number
    6000001-2011-02926
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K921899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION ON 05/11/2011. AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL EXAMINATION OF THE SAMPLE REVEALED A WHITE SHADOW INSIDE THE INTERLINK T-CONNECTOR. THE UNIT WAS THEN SUBMITTED FOR AN UNDERWATER PRESSURE TEST, AND A BLOCKAGE WAS OBSERVED WITHIN THE T-CONNECTOR. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE OF THIS CONDITION WAS ATTRIBUTED TO AN EXCESS OF SOLVENT APPLIED DURING THE MANUFACTURING PROCESS. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) AN INTERLINK SYSTEM T-CONNECTOR EXTENSION SET IN WHICH A NO FLOW OCCURRED. THE CONDITION WAS IDENTIFIED DURING USE. 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
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR09L13018

    Patients

    Seq Age Sex Outcome Treatment
    1