BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR

    MDR report key: 6136416 · Received November 30, 2016

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    1416980-2016-17808
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Report Date
    November 30, 2016
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K132734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT THERE WERE AIR BUBBLES IN THE TUBING OF A ONE-LINK CATHETER EXTENSION SET. THE CUSTOMER STATED THAT THE AIR APPEARED TO BE LEAKING INTO THE SET "AT THE CONNECTION SITE.¿ THIS WAS OBSERVED WHILE DRAWING BLOOD FOR LAB TESTING. THE DEVICE WAS BEING USED WITH A NON-BAXTER CATHETER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785681 EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 BD INSYTE CATHETER WITH BLOOD CONTROL VALVE