BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3000220 · Received March 12, 2013

    Report

    Report Number
    1416980-2013-05901
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K925126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE EVALUATION WAS PERFORMED WHICH IDENTIFIED THAT THE LEAK WAS FOUND TO BE DUE TO A CUT IN THE TUBING BELOW THE FEMALE LUER. THE ROOT CAUSE FOR THE REPORTED LEAK WAS DETERMINED TO BE DUE TO A CUT IN THE TUBING.

    Additional Manufacturer Narrative · 1

    (B)(4). TWO UNITS WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED. NO DEFECTS WERE OBSERVED. ONE UNIT FAILED THE PRESSURE TEST AT 8PSI DUE TO A LEAK NEAR THE FEMALE LUER LOCK. UNIT THAT DID NOT FAIL ALSO PASSED FUNCTIONAL TEST. THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED BY THE SAMPLE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(6) THAT THERE WAS A LEAK WITH AN INTERLINK I.V. CATHETER EXT SET/MALE II ADAPTER SET. THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE EXTENSION TUBING WAS FOUND LEAKING AND THERE WAS REFLUX INTO THE PICC LINE. THE DEVICE WAS FLUSHED AND A NEW EXTENSION SET WAS ATTACHED. THE PROBLEM WAS NOTED DURING PATIENT USE; THEREFORE, THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103790 ACCESS ADMINISTRATION, SET, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1