BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPANSION KIT: SILVER SOAKER CATHETER 2.5 INCH

    MDR report key: 3231465 · Received July 15, 2013

    Report

    Report Number
    2026095-2013-00122
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 17, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE SAMPLE HAS BEEN RECEIVED BY THE REPORTER FOR INSPECTION AND EVALUATION. CONCLUSION: A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION AND EVALUATION 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 AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: UNKNOWN. FILL VOLUME: NOT APPLICABLE. FLOW RATE: NOT APPLICABLE. PROCEDURE: BI-LATERAL TOTAL KNEE REPLACEMENT. CATHPLACE: RIGHT KNEE. THE PATIENT HAD KNEE SURGERY ON (B)(6) 2013. THE PHYSICIAN REPORTED THAT UPON REMOVAL OF THE CATHETER, RESISTANCE WAS MET. THE PATIENT WAS REPOSITIONED AND THEY TRIED AGAIN. IT WAS NOTED THAT TIME THAT THE BLACK TIP WAS MISSING. IT WAS ESTIMATED 3/4 INCH OF THE CATHETER WAS MISSING. THE PATIENT WAS X-RAYED BUT NO CATHETER REMNANT WAS VISIBLE. THERE WAS NO PATIENT INJURY OR SECONDARY INTERVENTION PERFORMED. THE PATIENT WAS DISCHARGED WITH NORMAL POST-OP TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327634 EXPANSION KIT: SILVER SOAKER CATHETER 2.5 INCH CATHETER BSO I-FLOW, LLC PM010-A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other