BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLELESS IV CONNECTOR

    MDR report key: 14957020 · Received July 7, 2022

    Report

    Report Number
    MW5110742
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    January 1, 2020
    Report Date
    June 24, 2022
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEEDLELESS IV CONNECTORS ARE NOT PROTECTED FROM SKIN CONTACT OR OTHER OBJECTS. A STUDY IN A US HOSPITAL FOUND THAT 23% OF IV-LINE CONNECTORS WERE CONTAMINATED WITH PATHOGENIC BACTERIA, DESPITE STRICT INFECTION CONTROL GUIDELINES THAT INCLUDED THE USE OF ALCOHOL LINED CAPS (HANKINS R, MAJORANT OD ET AL. MICROBIAL COLONIZATION OF INTRA VASCULAR CATHETER CONNECTORS IN HOSPITALIZED PATIENTS. AM J INFECTION CONTROL 2019; 47:1489). THIS COLONIZATION LEADS TO BIOFILM FORMATION AND SEEDING OF THE BACTERIA INTO THE PATIENTS BLOODSTREAM WHICH RESULTS IN LIFE THREATENING CENTRAL LINE ASSOCIATED BACTEREMIA (CLABSI). THE LACK OF A PASSIVE, MECHANICAL SHIELDS ON NEEDLE-LESS IV CONNECTORS RENDERS THESE CLASS 2 MEDICAL DEVICES UNNECESSARILY UNSAFE AND DANGEROUS. THEIR HUMAN FACTORS DEFECTIVE DESIGN IS FURTHER CONFIRMED BY THE FACT THAT NURSES ADMIT TO NOT DISINFECTING THEM PRIOR TO 3% OF ALL THE INFUSIONS. DELAHANTY KM, MYERS FE, ILL. NURSING 2009 I.V. INFECTION CONTROL SURVEY REPORT. NURSING 2009;39(12):24-30). THE 2020 CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION (CLABSL) RATE IS 0.87 PER 1,000 CENTRAL LINE DAYS. AN INFECTIOUS DISEASES EXPERT'S ESTIMATE IS 10,000,000 CENTRAL LINE DAYS IN THE US EVERY YEAR. OVER THREE YEARS, THIS WOULD ENTAIL 261,000 CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTIONS, MANY DEATHS, AND HUGE COSTS. AN ESTIMATED 7.5 % OF THESE INFECTIONS CAN BE ATTRIBUTED TO SUBOPTIMAL IV-CONNECTOR DESIGN ALLOWING CONTAMINATION WITH PATHOGENIC MICROORGANISMS. SUCH CONTAMINATION IS FOUND IN UP TO 23 % OF CONNECTORS, WHERE BIOFILM FORMATION LEADS TO PLANKTONIC SEEDING OF THE CATHETER - AND WHATEVER CLOTS MAY FORM AT THE CATHETER TIP. CLABSLS FOLLOW, ENDANGERING ROUGHLY 59,600 US PATIENTS, EACH OF WHOM FALLS UNDER THE REGULATORY SAFETY JURISDICTION OF THE FDA. "AVACARE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060962 NEEDLELESS IV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA
    2060963 NEEDLELESS IV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2200, INC.
    2060964 NEEDLELESS IV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION
    2060965 NEEDLELESS IV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC.
    2060966 NEEDLELESS IV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC.
    2060967 NEEDLELESS IV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA CARDINAL HEALTH 200, LLC
    2060968 NEEDLELESS IV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA BD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| H| L| R A CENTRAL LINE OR | A PIC LINE.| AN IV LINE, | DRUGS WHERE THE DISEASE OR THE CONDITION OF A PT NECESSITATE ADMINISTRATION THROUGH AND| MULTIPLE THAT ALL NECESSITATE INFUSION THROUGH A CENTRAL LINE BUT ARE NOT RELATED TO LINE INFECTIONS.