BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADMINISTRATION SETFLOWCONTROLLER

    MDR report key: 15932303 · Received December 6, 2022

    Report

    Report Number
    MW5113656
    Event Type
    Injury
    Date Received
    December 6, 2022
    Date of Event
    December 1, 2022
    Report Date
    December 2, 2022
    Manufacturer
    PROGRESSIVE MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    [ADMINISTRATION SET WITH FLOW CONTROLLER] USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA):[PRODUCT NAME] USE FOR COVIHOMED-19 UNDER EMERGENCY USE AUTHORIZATION (EUA):MEDICAL PRODUCT IV RATE CONTROLLED TUBING FOR IN HOME USE OF INTRAVENOUS MEDICATION ADMINISTRATION. MULTIPLE TUBING FAILURES SAME LOT NUMBER # 20220516. FLUID DOES NOT TRAVEL THROUGH IV LINE. THE PURPOSE OF IV TUBING IS TO GET MEDICATION TO TRAVEL DOWN THRU LINE THROUGH INTRAVENOUS VESSEL. THIS IS DANGEROUS TO PATIENTS HEALTH AND WELL NESS AS THEY COULD GET AN AIR BOLUS FROM THE DEFECTIVE TUBING SINCE IV MEDICATION/FLUID IS THE PRODUCT THAT NEEDS TO BE DELIVERED TO PATIENT. WE HAVE HAD 17 PACKAGES OF IV TUBING THAT HAVE BEEN TROUBLESHOOTED WITH OUT SUCCESS AND SO FAR HAVE AVERTED PATIENT HARM DUE TO OUR VIGILANT HOME INFUSION NURSES. THE PROCESS SHOULD BE AS FOLLOWS. PATIENT IS DISCHARGED HOME FROM HOSPITAL WITH IV ANTIBIOTICS RX(PRESCRIPTION). OUR PHARMACY PROVIDES MEDICATION, NURSE AND EQUIPMENT. PATIENT IS TRAINED BY REGISTERED NURSE TO ADMINISTER IV ANTIBIOTICS THROUGH THIS RATE CONTROLLED IV TUBING PROVIDED BY PROGRESSIVE MEDICAL LOT # 20220516 #PMIFR100, PRIME VOL. 28.2 LENGTH 100". THIS RATE CONTROLLED TUBING BATCH HAS HAD MULTIPLE FAILURES ADDING UP TO 17 TIMES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368967 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516
    368968 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516
    368969 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516
    368970 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516
    368971 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516
    368972 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516
    368973 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516
    368974 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516
    368975 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516
    368976 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516
    368977 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516
    368978 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516
    412170 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516
    412171 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516
    412172 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516
    412173 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516
    412174 ADMINISTRATION SETFLOWCONTROLLER SET, ADMINISTRATION, INTRAVASCULAR FPA PROGRESSIVE MEDICAL, INC. PMIFR100 20220516

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O ADMINISTRATION SET WITH FLOWCONTROLLER