BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESET W/TEO PORTS 39 TUBING

    MDR report key: 249558 · Received November 8, 1999

    Report

    Report Number
    1713468-1999-00055
    Event Type
    Malfunction
    Date Received
    November 8, 1999
    Date of Event
    October 1, 1999
    Report Date
    October 12, 1999
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    CBT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GENERAL REPORT OF MULTIPLE UNDOCUMENTED INCIDENCES OF BLEEDBACK INTO THE PRESSURE MONITORING TUBING. DURING USE ON PTS, IT WAS NOTED THAT BACKBLEED OCCURRED INTO THE TUBING. THE BACKBLEED WAS NOTED OCCASSIONALLY AS FAR BACK AS TO THE IV BAG AFTER ACCESS OF THE SAFESET PORT. THE CUSTOMER STATES THAT THIS IS OCCURRING POSSIBLY AFTER ACCESS OF THE PORT BY THE NURSES WITH A BAXTER 14G ACCESS PIN. OOZING HAS BEEN NOTED AT THE PORT. PT INFO WAS REQUESTED, BUT NONE WAS AVAILABLE. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFESET W/TEO PORTS 39 TUBING BLOOD SAMPLING PORT CBT ABBOTT LABORATORIES NA 53-162-SN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other POSSIBLE USE OF BAXTER 14G ACCESS PIN TO ACCESS| PORT