BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVER SOAKER 5IN: 270ML, DUAL 2+2 ML/HR

    MDR report key: 3113732 · Received May 10, 2013

    Report

    Report Number
    2026095-2013-00089
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 11, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO SAMPLE WILL BE RETURNED FOR A EVALUATION AND INVESTIGATION. THE SAMPLE WAS DISCARDED. RESULTS: WITHOUT THE ACTUAL PRODUCT A COMPLETE ANALYSIS CANNOT BE CONDUCTED. CONCLUSIONS: AT THIS TIME THE COMPLAINT IS UNDER INVESTIGATION AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. 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: UNKNOWN, FILL VOLUME: NOT APPLICABLE, FLOW RATE: NOT APPLICABLE, PROCEDURE: LAP GASTRIC SLEEVE, CATHPLACE: ABDOMEN, DATE OF SURGERY: ON (B)(6) 2013. AN ON-Q CATHETER BROKE UPON REMOVAL. THE CATHETER WAS NOT KEPT AND THE TIP REMAINS INSIDE THE PATIENT WITH NO PLANS TO REMOVE IT. THE PHYSICIAN IS AWARE AND EXAMINED THE PATIENT PRIOR TO DISCHARGE. IT WAS REPORTED BY THE PHYSICIAN THAT THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208821 SILVER SOAKER 5IN: 270ML, DUAL 2+2 ML/HR CATHETER BSO I-FLOW, LLC PM028-A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other