BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 5006399 · Received August 15, 2015

    Report

    Report Number
    1416980-2015-32562
    Event Type
    Malfunction
    Date Received
    August 15, 2015
    Date of Event
    July 11, 2015
    Report Date
    July 16, 2015
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; 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 CYSTOFLO URINARY DRAIN BAG LEAKED FROM A HOLE DURING URINE DRAINAGE. 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
    540944 IVT DISPOSABLE COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER KNX BAXTER HEALTHCARE - CALI SE15BQ8

    Patients

    Seq Age Sex Outcome Treatment
    1