BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3760314 · Received April 20, 2014

    Report

    Report Number
    1416980-2014-12760
    Event Type
    Malfunction
    Date Received
    April 20, 2014
    Report Date
    March 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K132734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING OF A ONE-LINK NEEDLE FREE IV NON-DEHP CATHETER EXTENSION SET RUPTURED AND LEAKED. THIS OCCURRED WHEN THE SET WAS BEING USED FOR INFUSION OF CONTRAST SOLUTION IN A CAT SCAN. THE TECHNICIAN HAD FLUSHED THE LINES WITH SALINE WITHOUT A PROBLEM AND THEN THE TUBING POPPED WHEN THE CONTRAST WAS STARTED. THE REPORTER FURTHER STATED THAT THE TUBING POPPED AT THE CONNECTOR SITE THAT WAS CONNECTED TO THE CATHETER SITE. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239161 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTRAST SOLUTION