BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLINK SYSTEM T-CONNECTOR EXTENSION SET

    MDR report key: 6134462 · Received November 30, 2016

    Report

    Report Number
    1416980-2016-17754
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 30, 2016
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K060074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS A (B)(6) BABY. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PEDIATRIC PATIENT EXPERIENCED A CONNECTION ISSUE WITH AN INTER LINK T-CONNECTOR. A T-CONNECTOR DISCONNECTED FROM THE PATIENT¿S ANGIOCATHETER AND RESULTED IN 0.2 ML OF BLOOD LOSS. THE SLIP LOCK DID NOT CONNECT PROPERLY TO THE NON-BAXTER 18 GAUGE ANGIOCATHETER THE PATIENT USES, WHICH CAUSED THE DISCONNECTION ISSUE RESULTING IN THE AREA BEING CLEANSED AND A NEW SETUP STARTED. THERE WAS NO MEDICAL INTERVENTION; HOWEVER, AS THE DISCONNECTION AND BLOOD LOSS REPRESENTS A BREACH OF THE STERILE FLUID PATHWAY, THERE WAS A RISK OF INFECTION TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787638 INTERLINK SYSTEM T-CONNECTOR EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other