BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y TYPE MICRO EXT SET

    MDR report key: 1993589 · Received February 16, 2011

    Report

    Report Number
    6000001-2011-01056
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    February 14, 2010
    Report Date
    January 31, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K925126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF THE SAMPLE IS AVAILABLE FOR EVALUATION. HOWEVER, IF THE CUSTOMER DECIDES TO SEND IN THE SAMPLE, A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN PERFORMED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A Y TYPE MICRO EXTENSION SET IN WHICH THE TUBING SNAPPED AT THE Y SITE. THIS SET WAS CONNECTED TO A PRIMARY LINE, AND THIS REPORTED CONDITION WAS DISCOVERED BY A NURSE AND IT OCCURRED DURING PATIENT-USE. HOWEVER, THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Y TYPE MICRO EXT SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R09H16059

    Patients

    Seq Age Sex Outcome Treatment
    1 PRIMARY LINE