BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2943770 · Received February 5, 2013

    Report

    Report Number
    1416980-2013-02954
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 11, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K103551
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE SAMPLE WAS RECEIVED FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A REVIEW OF 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: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THE CUSTOMER REPORTED CONDITION AS DAMAGED STERILE PACKAGING. THE ROOT CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE RELATED TO THE MANUFACTURING PROCESS. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. THIS ISSUE IS BEING INVESTIGATED THROUGH CORRECTIVE AND PREVENTATIVE ACTION (CAPA). THE MANUFACTURING FACILITY HAS IMPLEMENTED CORRECTIVE ACTIONS RELATED TO THE MANUFACTURING PROCESS AND RE-TRAINED THE TECHNICIANS INVOLVED IN THE SEALING PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER OF A V-LINK CATHETER EXTENSION SET THAT WAS ALLEGED WITH A POOR SEAL AT THE PERFORATION OF THE SET'S STERILE PACKAGING. THE CUSTOMER STATED THAT WHEN ONE PACKAGE WAS OPENED, THE NEXT PACKAGE CONNECTED WOULD ALSO OPEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47577 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R12I01054

    Patients

    Seq Age Sex Outcome Treatment
    1