BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2873344 · Received December 14, 2012

    Report

    Report Number
    1416980-2012-07345
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 7, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K060074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    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). A SAMPLE WAS RECEIVED AND THE PROBLEM WAS CONFIRMED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION OR IF RELEVANT ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION THE CUSTOMER REPORTED CONDITION WAS CONFIRMED, AS THE TUBING WAS FOUND TO BE CUT IN TWO PIECES. HOWEVER, THE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER HAD EMAILED IV THERAPY SPECIALIST REGARDING AN INTERLINK T-CON EXT SET/MICRO-BORE WHICH WAS CUT IN HALF WITH PACKAGE INTACT. PRODUCT SURVEILLANCE SPOKE WITH THE CUSTOMER REGARDING THE REPORTED INTERLINK DAMAGE. THE CUSTOMER STATED THAT THEY HAVE A SEALED PACKAGE OF THE INTERLINK WHERE THE PRODUCT INSIDE THE PACKAGE IS CUT IN HALF. THERE WAS NO PATIENT INVOLVEMENT, INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. 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 UR12D19123

    Patients

    Seq Age Sex Outcome Treatment
    1