BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 2133443 · Received June 15, 2011

    Report

    Report Number
    1036844-2011-00172
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    December 6, 2010
    Report Date
    June 9, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, WHILE IN THE OPERATING THEATRE, THE MD INSERTED THE PRODUCT VIA THE PATIENT'S RIGHT JUGULAR SITE. UPON INSERTION, THE PATIENT HAD AN ANAPHYLACTIC REACTION. THE PATIENT EXPERIENCED CARDIAC FAILURE, RESUSCITATION WAS NEEDED AND INOTROPES VENTILATED, ARAMINE AND ADRENALINE ADMINISTERED. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE. THE ARROWGARD BLUE CVC (CENTRAL VENOUS CATHETER) WAS REMOVED FOUR DAYS AFTER INSERTION, ON (B)(6) 2010. THERE WAS NO REPORTED PATIENT DEATH. THE PATIENT IS NOW OK AND HAS SINCE UNDERGONE THE NEPHRECTOMY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 FROM THE CLINICIAN STATED "UPON REFLECTION ON THIS CASE, IT HAS BEEN RECOGNIZED THAT THE PATIENT'S REACTION WAS POSSIBLY DUE TO THE AGB IMPREGNATION OF THE CATHETER." THE DISTRIBUTOR ALSO RECEIVED THE TGA REPORT FROM THE "ANONYMOUS" CUSTOMER WHICH STATED "ANAPHYLAXIS TO CHLORHEXIDINE RESULTING IN EMD, CARDIAC ARREST AND VF. CHLORHEXIDINE BECOMES MORE PERVASIVE IN HOSPITAL ENVIRONMENT AS A STERILIZING PREP, HAND WASH AND ASSOCIATED WITH MANY LINES AND GELS AND ADHESIVES. IT IS NOT A NONTOXIC SUBSTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other