BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK(TM)CONTINU-FLO SOLNSET 3INJ SITES 10DPM

    MDR report key: 1831942 · Received September 13, 2010

    Report

    Report Number
    6000001-2010-03086
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF LEAK WAS NOT CONFIRMED. TWO (2) COMPANION SAMPLES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION AND UNDERWATER PRESSURE TEST (8PSI) WAS CONDUCTED ON BOTH RETURNED SAMPLES WITH NO ABNORMALITY OBSERVED. BATCH REVIEW WAS CONDUCTED ON THE REPORTED BATCH WITH NO ABNORMALITY OBSERVED. NO ROOT CAUSE COULD BE DETERMINED. THIS REPORT WAS ORIGINALLY INCLUDED IN REPORT 6000001-2010-01041.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK THAT CAUSED A BLOOD BACKFLOW. THE LEAK OCCURS AT THE UPPER PORT AFTER INFUSING AN UNKNOWN IV PUSH DRUG WITH THE BD TWIN NEEDLE CANNULA. THE LEAK OCCURS ALMOST IMMEDIATELY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. THE AMOUNT OF BLOOD THAT BACKED UP IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK(TM)CONTINU-FLO SOLNSET 3INJ SITES 10DPM SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE S10A20111R

    Patients

    Seq Age Sex Outcome Treatment
    1