BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTOSCOPY IRRIGATION SET

    MDR report key: 6111496 · Received November 17, 2016

    Report

    Report Number
    1416980-2016-17430
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 17, 2016
    Report Date
    November 17, 2016
    Manufacturer
    BAXTER HEALTHCARE-CARTAGO
    Product Code
    LJH
    PMA / PMN Number
    K960787
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CYSTO/BLADDER IRRIGATION SET HAD AIR BUBBLES. THE PROCESS STEP WHEN THIS OCCURRED WAS NOT SPECIFIED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761102 CYSTOSCOPY IRRIGATION SET SYSTEM, IRRIGATION, UROLOGICAL LJH BAXTER HEALTHCARE-CARTAGO NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1