BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTOSCOPY IRRIGATION SET

    MDR report key: 6078945 · Received November 4, 2016

    Report

    Report Number
    1416980-2016-16940
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Report Date
    January 19, 2017
    Manufacturer
    BAXTER HEALTHCARE - CARTAGO
    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)(6). 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: UPON FURTHER FOLLOW UP WITH THE REPORTER, IT HAS BEEN DETERMINED THAT THE EXACT QUANTITY OF IRRIGATION SETS THAT LEAKED WAS REPORTED AS UNKNOWN; THEREFORE, THIS COMPLAINT HAS BEEN DETERMINED TO BE A DUPLICATE COMPLAINT OF (B)(4), SUBMITTED IN MDR (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING OF AN ACCESS IRRIGATION SET IS TOO LOOSE AND CAUSES SOLUTION TO SPRAY OUT. 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
    729909 CYSTOSCOPY IRRIGATION SET SYSTEM, IRRIGATION, UROLOGICAL LJH BAXTER HEALTHCARE - CARTAGO NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1