BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC HYDROKIT

    MDR report key: 3181395 · Received June 14, 2013

    Report

    Report Number
    3009632672-2013-00014
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    January 6, 2012
    Manufacturer
    WELLSPECT HEALTHCARE
    Product Code
    GBM
    PMA / PMN Number
    K043241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUBMISSION IS BEING MADE AFTER AN ACQUISITION AND INTERNAL AUDIT OF WELLSPECT HEALTHCARE. ANALYZING THE RETURNED SAMPLE SHOWS NO DEFECTS OR DEVIATIONS. ANALYZING THE BATCH DOCUMENTATION, HOWEVER, REVEALS THAT THIS BATCH WAS PRODUCED WHEN A MANUFACTURING PROCESS PROBLEM OCCURRED. THE FAULTY PRODUCTS IN THE BATCH WAS SORTED OUT AND DISCARDED. UNFORTUNATELY, SOME FAULTY PROBLEMS MAY HAVE REACHED THE CUSTOMER AND DUE TO A LEAKING SACHET HAVE CAUSED THE CATHETER COATING TO CRYSTALLIZE. THE MANUFACTURING PROBLEM HAS BEEN SOLVED AND AN AUTOMATED CONTROL FUNCTION HAS BEEN INSTALLED.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED SOME RESISTANCE WHEN CATHETERIZING. AFTER CATHETERIZATION SOME BLOOD WAS VISIBLE ON THE CATHETER TIP. NEXT CATHETERIZATION THE SAME THING HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270661 LOFRIC HYDROKIT CATHETER URETHRAL, GBM GBM WELLSPECT HEALTHCARE 98312 93449

    Patients

    Seq Age Sex Outcome Treatment
    1 Other