BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV TUBING

    MDR report key: 15758831 · Received November 9, 2022

    Report

    Report Number
    15758831
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    September 21, 2022
    Report Date
    November 1, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN DISCONNECTED IV LINE AT CONCLUSION OF HIC DRUG# (B)(4) CHEMOTHERAPY INFUSION. DUE TO BACK PRESSURE FROM IV LINE, INVESTIGATIONAL DRUG SPLASHED FROM IV TUBING INTO RN'S EYE UPON DISCONNECTION. RN FLUSHED EYE IMMEDIATELY AND REPORTED TO OCCUPATIONAL HEALTH IMMEDIATELY FOR EVALUATION. PER OCCUPATIONAL HEALTH, NEEDLESTICK PANEL WITH HIV SOURCE PATIENT TO BE DRAWN ON PATIENT. IV TUBING SEQUESTERED AND SENT TO PHARMACY. EMPLOYEE FOLLOWING UP WITH OCCUPATIONAL HEALTH PER OCCUPATIONAL HEALTH RECOMMENDATIONS. MANUFACTURER RESPONSE FOR IV TUBING, IV TUBING (PER SITE REPORTER) ONGOING ISSUE WITH BAXTER TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2948271 IV TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown