BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION ADMINISTRATION SET

    MDR report key: 13862095 · Received March 22, 2022

    Report

    Report Number
    MW5108413
    Event Type
    Injury
    Date Received
    March 22, 2022
    Date of Event
    March 19, 2022
    Report Date
    March 19, 2022
    Manufacturer
    MOOG / ZEVEX, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TONIGHT WHEN WE HOOKED UP TPN THE TUBING WAS DEFECTIVE AND LEAKING BADLY. THERE WAS A HOLE IN THE TUBING CLOSE TO THE 1.2 MICRON FILTER. THE LOT NUMBER ON THE DEFECTIVE TUBING WAS; CF2201719 2027-01-17, REF # (B)(4). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304422 INFUSION ADMINISTRATION SET PUMP, INFUSION FRN MOOG / ZEVEX, INC. 340-4128 CF2201719

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female Required Intervention IV NUTRITION | MULTIVITAMIN | OMEGAVEN| TPN