BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q C-BLOCK W/DUALSAF 400ML, 1-7ML/HR+1-7ML/HR

    MDR report key: 2822446 · Received November 2, 2012

    Report

    Report Number
    2026095-2012-00263
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    August 19, 2012
    Report Date
    October 5, 2012
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE SAMPLE HAS BEEN RECEIVED BY THE REPORTER FOR INSPECTION AND EVALUATION. RESULTS - TESTING IS CURRENTLY BEING PERFORMED ON THE RETURNED UNIT. CONCLUSION - A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.1%. FILL VOLUME: 400 ML. FLOW RATE: 4 ML/HR. PROCEDURE: RECONSTRUCTIVE BREAST SURGERY WITH FREE TISSUE TRANSFER OF DEEP INFERIOR EPIGASTRIC PERFORATOR FLAP. CATHPLACE: PLACED INTRAOPERATIVELY ON (B)(6) 2012 TO LEFT AND RIGHT HIP AREA. CATHETER BROKE INSIDE THE PATIENT ON (B)(6) 2012, UPON REMOVAL. WHEN REMOVING THE CATHETER RESISTANCE WAS ENCOUNTERED, RN REMOVING THE CATHETER REPLAYED THAT IT DIDN'T SEEM ANY MORE OF A TUG THEN OTHER TIMES THAT SHE DISCONNECTED CATHETERS. THE CATHETER APPEARED TO HAVE A CLEAN CUT AND THE BLACK TIP WAS NOT VISIBLE. THE CATHETER SEGMENT WAS LEFT INSIDE THE PATIENT AND IT WAS REPORTED THAT IT WILL BE REMOVED DURING THE PATIENT'S SECOND ROUND OF RECONSTRUCTIVE BREAST SURGERY. AT THIS TIME THE DATE OF THE SECOND ROUND OF SURGERY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOCK W/DUALSAF 400ML, 1-7ML/HR+1-7ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC CB4007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other