BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD ACCESS SYSTEMS

    MDR report key: 1900967 · Received November 12, 2010

    Report

    Report Number
    MW5018192
    Event Type
    Injury
    Date Received
    November 12, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE USE OF ETHANOL LOCKS TO PREVENT CATHETER-RELATED BLOODSTREAM INFECTIONS IS BECOMING AN INCREASINGLY WIDESPREAD PRACTICE. THIS IS A PROMISING THERAPY, BUT IS NOT WITHOUT RISKS. ETHANOL HAS BEEN SHOWN TO DEGRADE CERTAIN FORMULATIONS OF POLYURETHANE. THE EXISTING MEDICAL LITERATURE IS ALSO INCOMPLETE SINCE NOT ALL FORMULATIONS OF POLYURETHANE HAVE BEEN TESTED AFTER PROLONGED EXPOSURE TO ETHANOL. ETHANOL IS SAFE FOR USE IN SILICONE CATHETERS. AT OUR INSTITUTION, WE SUSPECT THERE HAVE BEEN 2 CATHETER FAILURES (BREAKAGE OF LINE) RELATED TO THE USE OF ETHANOL IN POLYURETHANE CENTRAL VENOUS CATHETERS. ONE OF THE CATHETERS WAS RETURNED TO MFR (POWERLINE), THE OTHER (IMPLANTABLE PORT) WAS NOT. ALTHOUGH COMPANIES' INSTRUCTIONS FOR USE (IFU) WARN AGAINST USING ETHANOL IN POLYURETHANE CENTRAL VENOUS CATHETERS, ONCE A CATHETER IS PLACED, THERE IS NO DISTINGUISHING FEATURE THAT PERMITS A PROVIDER TO KNOWN THE ACTUAL COMPOSITION OF THE CATHETER PARTICULARLY IF THAT PROVIDER WAS UNINVOLVED IN THE PLACEMENT OF THE CATHETER. THIS IS MADE EVEN MORE COMPLEX BY THE FACT THAT MANY PATIENTS HAVE MULTIPLE CATHETERS PLACED THROUGHOUT THEIR LIFETIME. IN ORDER TO PREVENT INADVERTENT CATHETER FAILURE; WE BELIEVE THERE NEEDS TO BE A COORDINATED EFFORT FROM ALL U.S. DEVICE MFRS. THERE NEEDS TO BE AN UNAMBIGUOUS INDUSTRY STANDARD THAT CLEARLY DIFFERENTIATES SILICONE FROM POLYURETHANE CATHETERS. SUCH LABELING MUST BE INDELIBLE, EASILY SEEN AND CONSISTENT ACROSS MFRS. THERE WILL BE MORE CATHETER FAILURES AS ETHANOL LOCKS SEE INCREASED USE IF THIS IS NOT ADDRESSED IMMEDIATELY. (B)(4).

    Description of Event or Problem · 2

    THE USE OF ETHANOL LOCKS TO PREVENT CATHETER-RELATED BLOODSTREAM INFECTIONS IS BECOMING AN INCREASINGLY WIDESPREAD PRACTICE. THIS IS A PROMISING THERAPY, BUT IS NOT WITHOUT RISKS. ETHANOL HAS BEEN SHOWN TO DEGRADE CERTAIN FORMULATIONS OF POLYURETHANE. THE EXISTING MEDICAL LITERATURE IS ALSO INCOMPLETE SINCE NOT ALL FORMULATIONS OF POLYURETHANE HAVE BEEN TESTED AFTER PROLONGED EXPOSURE TO ETHANOL. ETHANOL IS SAFE FOR USE IN SILICONE CATHETERS. AT OUR INSTITUTION, WE SUSPECT THERE HAVE BEEN 2 CATHETER FAILURES (BREAKAGE OF LINE) RELATED TO THE USE OF ETHANOL IN POLYURETHANE CENTRAL VENOUS CATHETERS. ONE OF THE CATHETERS WAS RETURNED TO MFR (POWERLINE), THE OTHER (IMPLANTABLE PORT) WAS NOT. ALTHOUGH COMPANIES' INSTRUCTIONS FOR USE (IFU) WARN AGAINST USING ETHANOL IN POLYURETHANE CENTRAL VENOUS CATHETERS, ONCE A CATHETER IS PLACED, THERE IS NO DISTINGUISHING FEATURE THAT PERMITS A PROVIDER TO KNOW THE ACTUAL COMPOSITION OF THE CATHETER PARTICULARLY IF THAT PROVIDER WAS UNINVOLVED IN THE PLACEMENT OF THE CATHETER. THIS IS MADE EVEN MORE COMPLEX BY THE FACT THAT MANY PATIENTS HAVE MULTIPLE CATHETERS PLACED THROUGHOUT THEIR LIFETIME. IN ORDER TO PREVENT INADVERTENT CATHETER FAILURE; WE BELIEVE THERE NEEDS TO BE A COORDINATED EFFORT FROM ALL U.S. DEVICE MFRS. THERE NEEDS TO BE AN UNAMBIGUOUS INDUSTRY STANDARD THAT CLEARLY DIFFERENTIATES SILICONE FROM POLYURETHANE CATHETERS. SUCH LABELING MUST BE INDELIBLE, EASILY SEEN AND CONSISTENT ACROSS MFRS. THERE WILL BE MORE CATHETER FAILURES AS ETHANOL LOCKS SEE INCREASED USE IF THIS IS NOT ADDRESSED IMMEDIATELY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ACCESS SYSTEMS POWERLINE CVC (6FR), LJS BARD ACCESS SYSTEMS 0700615
    2 BARD ACCESS SYSTEMS TITANIUM PORT LJT BARD ACCESS SYSTEMS 0607530

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization| L| O| R
    2 5 YR Hospitalization| L| O| R