BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSHIELD IRRIGATOR

    MDR report key: 4030906 · Received July 18, 2014

    Report

    Report Number
    1528319-2014-00010
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 17, 2014
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    KOG
    PMA / PMN Number
    K070420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. REVIEW OF THE LOT HISTORY RECORD (00711133 LOT 1411776, MANUFACTURED JUNE 2014, 30 BX) INDICATES NO ANOMALIES IN THE MANUFACTURE OF THE LOT. A REVIEW OF COMPLAINT HISTORY FINDS NO OTHER COMPLAINTS ASSOCIATED WITH BIOSHIELD IRRIGATOR 00711133 LOT 1411776. THE CUSTOMER REPORT NO HARM TO THE PATIENT OR USERS, AND NO MEDICAL ATTENTION REQUIRED. THE USERS WERE WEARING THE EXPECTED PPE. (B)(4) AND ASGE TECHNICAL GUIDELINES REQUIRE FACILITY TO PROVIDE, AND WEAR, APPROPRIATE PROTECTIVE EQUIPMENT.

    Description of Event or Problem · 1

    A COMPLAINT WAS SUBMITTED THROUGH A US ENDOSCOPY PRODUCT SPECIALIST, CONCERNING CUSTOMER EXPERIENCE WITH USE OF BIOSHIELD IRRIGATOR (00711133 LOT 141776), DURING WHICH THE VALVE CAP OPENED AND TWO USERS (CUSTOMER AND PHYSICIAN) WERE SPRAYED WITH BODILY FLUIDS. IN FOLLOW UP COMMUNICATIONS, THE CUSTOMER STATE NO ONE WAS INJURED, NO TREATMENT WAS REQUIRED. THE CUSTOMER ALSO STATED ALL USERS WERE WEARING PPE AND NO INCIDENT REPORT WAS FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423884 BIOSHIELD IRRIGATOR BIOPSY VALVE KOG UNITED STATES ENDOSCOPY GROUP, INC. 00711133 1411776

    Patients

    Seq Age Sex Outcome Treatment
    1