BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE FILLED SYRINGE, 10ML FILL IN 10ML DIAMETER

    MDR report key: 5827041 · Received July 27, 2016

    Report

    Report Number
    1911916-2016-00010
    Event Type
    Injury
    Date Received
    July 27, 2016
    Date of Event
    May 1, 2016
    Report Date
    August 22, 2016
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FOZ
    PMA / PMN Number
    K003553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION H, DEVICE EVALUATION: RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. THERE WERE NO QNS OR ISSUES ASSOCIATED WITH THE REPORTED LOT 6098603. THERE IS NO DOCUMENTATION FOR ANY BRIDGING, OR ISSUES AFFECTING PRODUCT. ALL OUR INSPECTIONS PERFORMED WHILE MANUFACTURING THIS BATCH WERE ACCEPTED; NO ISSUES OR REJECTIONS WERE DOCUMENTED. CONCLUSION - BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. ALL INSPECTIONS/TESTING PERFORMED FROM MOLDING THROUGH THE CASE PACK WERE ACCEPTABLE WITH NO REJECTIONS RECORDED. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF EVENT IS UNKNOWN. THE CUSTOMER REPORTED THE EVENT OCCURRED IN (B)(6) 2016. DEVICE EVALUATION: IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS RECEIVING HOME INFUSION OF IVIG. ON HER THIRD ROUND OF INFUSION IN (B)(6) 2016, WHEN THE VISITING NURSE FLUSHED HER IV ACCESS WITH THE SUSPECT DEVICE, THE CUSTOMER EXPERIENCED AN ALCOHOL TASTE IN HER MOUTH AND AN INCREASE IN HEART RATE. THE CUSTOMER WENT TO THE DOCTOR WHO PRESCRIBED 50ML BENADRYL IV TO BE ADMINISTERED PRIOR TO INFUSIONS AND AN EPIPEN TO BE USED AS NEEDED. THE CUSTOMER NOTED THAT HER VISITING NURSE USED A REGULAR SYRINGE INSTEAD OF A BD POSIFLUSH⠁ND THE CONSUMER DID NOT HAVE ANY ADVERSE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479832 BD POSIFLUSH¿ NORMAL SALINE FILLED SYRINGE, 10ML FILL IN 10ML DIAMETER FLUSH SYRINGE, SALINE FOZ BD MEDICAL (BD WEST) MEDICAL SURGICAL 6098603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention