BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3122063 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13005
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K081289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. A BATCH REVIEW WILL BE CONDUCTED SINCE THE LOT NUMBER OF THE DEVICE IS KNOWN. SHOULD THE DEVICE OR ANY ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAK WAS OBSERVED ON A V-LINK CATHETER EXTENSION SET. ACCORDING TO THE REPORT, WHEN THE EXTENSION SET WAS ATTACHED TO AN UNKNOWN CATHETER, BLOOD LEAKED OUT FROM THE "BROWN END" OF THE SET. THE EVENT OCCURRED SHORTLY AFTER IV INSERTION. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223898 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR13B06131

    Patients

    Seq Age Sex Outcome Treatment
    1