BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML

    MDR report key: 1266149 · Received December 5, 2008

    Report

    Report Number
    MW5009262
    Event Type
    Injury
    Date Received
    December 5, 2008
    Report Date
    December 5, 2008
    Manufacturer
    MEDEFIL, INC.
    Product Code
    NZW
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    I WOULD LIKE TO MAKE YOU AWARE OF A POTENTIAL PATIENT SAFETY PROBLEM WITH MEDEFIL, INC. PRESERVATIVE FREE HEPARIN I.V. FLUSH SYRINGE, BOTH THE 2 ML FILL IN A 6 ML SYRINGE AND THE 5 ML FILL IN A 6 ML SYRINGE; PRODUCTS. DUE TO MANUFACTURING LIMITATIONS, THESE PRE-FILLED FLUSH SOLUTIONS FOR INJECTION ARE PACKAGED WITH APPROXIMATELY ONE ML OF GAS WITHIN THE SYRINGE. IN THE "DIRECTIONS FOR USE" CONTAINED WITHIN THE PACKAGE INSERT INSTRUCTIONS STATE; "4. REMOVE TIP CAP. ATTACH A COMPATIBLE HYPODERMIC NEEDLE OR NEEDLE FREE DEVICE. HOLD SYRINGE UPRIGHT, AND EXPEL ANY AIR BUBBLE IF PRESENT. SYRINGE IS NOW READY TO USE." IN MY OPINION, PACKAGING WITH GAS IN THE SYRINGE PROMOTES THE PROBABILITY OF ACCIDENTAL INTRAVENOUS INJECTION OF GAS INTO A PATIENT. I WOULD ENCOURAGE YOU TO CONSIDER RE-LABELING WITH A CLEAR BAND OF NO GREEN BACK-GROUND FOR THE FIRST 2 ML OF THE SYRINGE BARREL SO THE GAS IS MORE READILY IDENTIFIED. ALTHOUGH INADVERTENT INJECTION OF GAS INTO AN ADULT PATIENT MAY BE OF LITTLE OR NO CONSEQUENCE; IN A CASE REPORT BY WALD, M, ET AL OF A 27 WEEKS OF GESTATION INFANT WITH A BIRTH WEIGHT OF 384 G <3RD PERCENTILE, THEY CONCLUDE: "CONSIDERING THE WEIGHT OF THE PREMATURE INFANT PRESENTED HERE, WE DEDUCE THAT A BOLUS OF 0.08CE0.16 ML OR A SLOW INFUSION OF 0.6 ML/MIN WOULD BE ENOUGH TO CAUSE FATAL RIGHT VENTRICULAR FAILURE." MY CONCERNS ARISE FROM THE FOLLOWING: THE GREEN LABEL SYRINGE COVERS ALL BUT ROUGHLY ONE-QUARTER OF THE SYRINGE BARREL PREVENTING VISUAL INSPECTION AND AWARENESS OF THE GAS WITHIN THE PRODUCT. A REGISTERED NURSE CAN EASILY REMOVE YOUR PRODUCT FROM THE PLASTIC PACKAGING WRAPPER, REMOVE THE TIP CAP; CONNECT TO A LUER-ACTIVATED NEEDLELESS I.V. OCCLUSION DEVICE AND INJECT THE SYRINGE CONTENTS WITHOUT EVER SEEING THE GAS WITHIN THE SYRINGE. IF THE PATIENT IS A SMALL NEONATE, INJECTION OF A BOLUS OF LESS THAN 0.5 ML AIR IS POTENTIALLY FATAL. REFERENCE: WALD, M, KIRCHNER, L ET AL FIFATAL AIR EMBOLISM IN AN EXTREMELY LOW BIRTH WEIGHT INFANT: CAN IT BE CAUSED BY INTRAVENOUS FL INTENSIVE CARE MED -2003- 29:630CE633 DOI 10.1007/S00134-003-1681-7 NEONATAL AND PEDIATRIC INTENSIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML NONE NZW MEDEFIL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening