BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSED IV SET SET, IV EXTENSION QUADFURCATED MICROBORE TUBING 57

    MDR report key: 13026207 · Received December 16, 2021

    Report

    Report Number
    MW5106148
    Event Type
    Injury
    Date Received
    December 16, 2021
    Date of Event
    December 7, 2021
    Report Date
    December 14, 2021
    Manufacturer
    UNK
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    TWO PATIENTS WERE FOUND TO HAVE HAD CENTRAL LINE WITH HA AND LIPIDS RUNNING PER ORDERS. FILTER ON THE HA TUBING FOUND TO BE LEAKING LEADING TO POTENTIAL BREAK IN CENTRAL LINE. MEDICAL TEAM AWARE. UNABLE TO DISCONTINUE PICC LINE DUE TO CRITICAL ACCESS ON PATIENT. IV TUBING, FLUID AND FILTER CHANGED USING STERILE TECHNIQUE PER ORDERS. METROMED, INC. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921597 CLOSED IV SET SET, IV EXTENSION QUADFURCATED MICROBORE TUBING 57 SET, ADMINISTRATION, INTRAVASCULAR FPA UNK
    1921598 CLOSED IV SET SET, IV EXTENSION QUADFURCATED MICROBORE TUBING 57 SET, ADMINISTRATION, INTRAVASCULAR FPA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention