BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD VACUTAINER STRETCH LATEX FREE TOURNIQUET

    MDR report key: 2003188 · Received February 16, 2011

    Report

    Report Number
    1519375-2011-00001
    Event Type
    Other
    Date Received
    February 16, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 16, 2011
    Manufacturer
    HYGENIC CORP.
    Product Code
    GAX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BD VACUTAINER STRETCH LATEX FREE TOURNIQUET IS MADE SPECIFICALLY FOR PRACTITIONERS AND THE FACILITIES THAT CHOOSE TO ELIMINATE LATEX FROM THEIR HEALTH CARE PRODUCTS. THIS PRODUCT IS MADE WITH SYNTHETIC POLYISOPRENE WHICH WILL NOT CAUSE A LATEX-INDUCED ALLERGIC REACTION IN LATEX-SENSITIVE PATIENTS OR EMPLOYEES. THIS DEVICE HAS A VANILLA SCENT THAT MASKS THE NATURAL ODOR OF THE PRODUCT, WHICH FROM MARKETING TESTING, WAS NOT PLEASING. A COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE IDENTIFIED LOT AND THIS IS THE FIRST RECORDED COMPLAINT. THE CUSTOMER RETURNED PRODUCT FROM THE LOT THEY REPORTED BUT NOT THE ACTUAL TOURNIQUET WHICH WAS INVOLVED IN THE REPORTED INCIDENT. NO ISSUES WERE FOUND WITH THE RETURNED PRODUCT. ALL BATCH RECORDS ASSOCIATED WITH THE LOT WERE REVIEWED AND THE RAW MATERIALS AS WELL AS THE PROCESSING PARAMETERS WERE WITHIN SPECIFICATIONS. IT WAS ALSO CONFIRMED THAT THERE WERE NO CHANGES MADE TO THE RAW MATERIALS, SUPPLIERS OF RAW MATERIALS OR FORMULATION OF THE PRODUCT. THE CYTOTOXICITY, SKIN SENSITIZATION AND SKIN IRRITATION STUDIES WHICH WERE PERFORMED DID NOT REVEAL ANY EVIDENCE THAT THERE IS A POTENTIAL FOR THE PRODUCT TO CAUSE ANY ALLERGIC REACTION AS WAS REPORTED. REGULATORY COMPLIANCE WILL CONTINUE TO TRACK AND TREND THIS CONDITION ON A MONTHLY BASIS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A TOURNIQUET WAS BEING USED BY A PHLEBOTOMIST WHO EXPERIENCED THROAT IRRITATION FROM THE SMELL OF THE TOURNIQUET AND SKIN IRRITATION WITH THE USE. THE PHLEBOTOMIST WENT TO THE EMPLOYEE HEALTH DEPARTMENT AND THEN TO THE EMERGENCY DEPARTMENT. THE ED PHYSICIAN CONFIRMED THERE WAS A "REACTION TO SOMETHING". NO ADD'L INFO WAS MADE AVAILABLE DUE TO PRIVACY CONSIDERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD VACUTAINER STRETCH LATEX FREE TOURNIQUET TOURNIQUET GAX HYGENIC CORP. NA OK002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other