BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3122840 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13058
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    BRZ
    PMA / PMN Number
    K993120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.THE PHOTOGRAPHIC INSPECTION CONFIRMED THE REPORTED CONDITION. THE CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK Y-TYPE BLOOD SET HAD LEAKED BETWEEN THE SPIKE (RIGID WHITE COMPONENT) AND THE TUBING AFTER SPIKING. THIS OCCURRED WHILE INFUSING BLOOD INTO THE PATIENT. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224449 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - AIBONITO UR13B14028

    Patients

    Seq Age Sex Outcome Treatment
    1