BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVER SOAKER CATHETER

    MDR report key: 3309980 · Received August 20, 2013

    Report

    Report Number
    2026095-2013-00132
    Event Type
    Injury
    Date Received
    August 20, 2013
    Date of Event
    June 7, 2013
    Report Date
    July 22, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE SUSPECT CATHETER WILL NOT BE RETURNED FOR AN EVALUATION AND INVESTIGATION. RESULTS: THE LOT AND MODEL NUMBERS WERE NOT RECEIVED; THEREFORE, I-FLOW CANNOT REVIEW THE DEVICE HISTORY RECORDS (DHR). CONCLUSIONS: A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: NOT APPLICABLE. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: TOTAL KNEE REPLACEMENT. CATHPLACE: LEFT KNEE., (2026095-2013-00132/13-00757). ADDITIONAL INFORMATION RECEIVED (B)(4) 2013: AT THIS TIME THE HOSPITAL DECIDED NOT TO RETURN THE SUSPECT CATHETER. AT THIS TIME, THE RISK MANAGER IS ATTEMPTING TO OBTAIN PHOTOGRAPHS OF THE SUSPECT CATHETER. REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403517 SILVER SOAKER CATHETER CATHETER BSO I-FLOW, LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other