BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4903296 · Received July 9, 2015

    Report

    Report Number
    1416980-2015-28274
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 23, 2015
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    LJH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A PUSH-PULL TEST WAS PERFORMED ON ALL SET¿S JUNCTIONS WITH NO DISCONNECTIONS NOTED. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ¿TIP ON THE END¿ OF AN UROMATIC ADMINISTRATION SET POPPED OFF DURING AN UNSPECIFIED PROCEDURE. THE SET WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO 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
    446280 ACCESS SYSTEM, IRRIGATION, UROLOGICAL LJH BAXTER HEALTHCARE - MALTA 14I01V842M

    Patients

    Seq Age Sex Outcome Treatment
    1