BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PI CVC KIT: 3-L 7 FR X 20 CM AGB

    MDR report key: 6192689 · Received December 21, 2016

    Report

    Report Number
    1036844-2016-00685
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    September 1, 2016
    Report Date
    November 30, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE WILL BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE COMPLAINT OF AN ALLERGIC REACTION TO THE ANTIMICROBIAL CATHETER WAS CONFIRMED. THE COMPLAINT REPORT WAS REVIEWED; HOWEVER, NO SAMPLE WAS RETURNED FOR ANALYSIS. THE PRODUCT LABEL AND THE CATHETER TECHNOLOGY INFORMATION SHEET INCLUDE WARNINGS AND PRECAUTIONS REGARDING ANTIMICROBIAL RELATED ANAPHYLAXIS. THE ARROWGARD BLUE PLUS ANTIMICROBIAL SHEATH IS CONTRAINDICATED FOR "PATIENTS WITH KNOWN HYPERSENSITIVITY TO CHLORHEXIDINE ACETATE, SILVER SULFADIAZINE AND/OR SULFA DRUGS." A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON SALES HISTORY AND DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. A RISK EVALUATION WAS COMPLETED FOR THIS COMPLAINT ISSUE. A REACTION WAS REPORTED UPON INSERTION OF THE ANTIMICROBIAL CATHETER INTO A PATIENT WITH HYPERSENSITIVITY TO SULFA. IT WAS NOT REPORTED IF THE HYPERSENSITIVITY WAS KNOWN PRIOR TO CATHETER INSERTION OR DISCOVERED AFTER INSERTION. OPERATIONAL CONTEXT RELATED TO THE PATIENT'S HYPERSENSITIVITY TO SULFA CAUSED OR CONTRIBUTED TO THIS EVENT. NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED OVER A PERIOD OF SEVERAL MONTHS, FOUR PATIENTS WITH HYPERSENSITIVITY TO SULFA WERE GIVEN THE (B)(4) CATHETER. ONE OF THESE PATIENTS HAD AN ALLERGIC REACTION AND REQUIRED ADDITIONAL TREATMENT. THEY DO NOT KNOW IF THERE WAS A DELAY IN TREATMENT AND THERE WAS NO PATIENT DEATH REPORTED. PER ADDITIONAL INFORMATION IT IS BELIEVED THAT ONLY ONE PATIENT NEEDED ADDITIONAL MEDICAL ATTENTION AND THE OTHER THREE HAD NO ISSUES. NO ADDITIONAL INFORMATION IS AVAILABLE FROM THE CUSTOMER. ON (B)(6) 2016 THE SALES REP WAS MADE AWARE OF AN EVENT WITH NO DETAILS PROVIDED. A FOLLOW UP MEETING OCCURRED ON (B)(6) 2016 WHERE ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842398 PI CVC KIT: 3-L 7 FR X 20 CM AGB ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention