BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK T-CON EXT SET/MICRO-BORE W/MLL ADT DN003

    MDR report key: 2061092 · Received April 18, 2011

    Report

    Report Number
    6000001-2011-02924
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K921899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) AN INTERLINK SYSTEM T-CONNECTOR EXTENSION SET IN WHICH A LEAK OCCURRED. ACCORDING TO THE REPORT, THE EXTENSION SET WAS ATTACHED TO AN INSYTE CATHETER. BLOOD STARTED BACKING UP THE CATHETER INTO THE INTERLINK SYSTEM AND LEAKED. UPON INSPECTION, IT APPEARS THE LEAK CAME FROM A VERTICAL CRACK IN THE INTERLINK HOUSING. WHEN FLUSHED, SALINE CAME OUT OF THE CRACK. THE CONDITION OCCURRED DURING PATIENT USE. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS COMPLAINT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK T-CON EXT SET/MICRO-BORE W/MLL ADT DN003 SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE| INSYTE CATHETER