BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2972913 · Received February 21, 2013

    Report

    Report Number
    1416980-2013-04387
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K811078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - EVALUATION IS PENDING RECEIPT OF THE SAMPLE. UPON COMPLETION OF THE EVALUATION, OR SHOULD ANY ADDITIONAL INFORMATION BE MADE AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, A BATCH REVIEW COULD NOT BE CONDUCTED. THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A BAXTER REPRESENTATIVE A CONDITION OF ONE Y-TYPE CATHETER EXTENSION SET THAT WAS ALLEGED WITH PACKAGING THAT OPENS PREMATURELY - WHEN ONE PACKAGE TORN FROM OTHERS, THE OTHER PACKAGE WILL OPEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. THIS IS REPORT #2 OF 4 REGARDING THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77206 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1