BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4974833 · Received August 5, 2015

    Report

    Report Number
    1416980-2015-31661
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Report Date
    October 30, 2015
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    LJH
    PMA / PMN Number
    K960787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION OUT OF ITS POUCH AND UNUSED. VISUAL INSPECTION DID NOT IDENTIFY ANY HAIR ON THE SET BUT DID IDENTIFY SEVERAL SECTIONS OF TUBING WITH BLACK INK MARKS ON THE SURFACE. THE INK MARKS WERE EASILY REMOVED WITH AN ALCOHOL SWAB. THE CAUSE OF THE CONDITION WAS UNABLE TO DETERMINED. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THERE WERE A HAIR ON THE TUBING OF A Y-TYPE IRRIGATION SET. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. 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
    514598 ACCESS SYSTEM, IRRIGATION, UROLOGICAL LJH BAXTER HEALTHCARE R14I23049

    Patients

    Seq Age Sex Outcome Treatment
    1