BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUIPO COLLEAGUE P/ INF MACRO

    MDR report key: 1968170 · Received January 21, 2011

    Report

    Report Number
    6000001-2011-00389
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - SAO PAULO
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION FOR THE REPORTED CONDITION OF A LEAK AT THE INJECTION SITE. A VISUAL EXAMINATION OF THE SAMPLE REVEALED A KINKY ELASTOMER IN THE INJECTION SITE WHICH CONFIRMED THE REPORTED CONDITION. THE ROOT CAUSE OF THIS CONDITION WAS ATTRIBUTED TO AN UNDETECTED PROCESS ISSUE. THE INJECTION SITE USED IN THIS SET IS MANUFACTURED BY AN EXTERNAL SUPPLIER, AND THIS MALFUNCTION WAS COMMUNICATED TO THE MANUFACTURER SO THEY CAN PERFORM A CORRECTIVE ACTION. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A SOLUTION SET THAT HAD A LEAK AT THE INJECTION SITE. THE CONDITION OCCURRED DURING PATIENT 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 EQUIPO COLLEAGUE P/ INF MACRO SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SAO PAULO PE29X5

    Patients

    Seq Age Sex Outcome Treatment
    1