BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 1081623 · Received July 25, 2008

    Report

    Report Number
    2026095-2008-00090
    Event Type
    Other
    Date Received
    July 25, 2008
    Date of Event
    May 26, 2008
    Report Date
    June 27, 2008
    Manufacturer
    I-FLOW CORP
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. IT WAS INDICATED THAT THE DEVICE WAS DISCARDED BY THE CUSTOMER, AND THEREFORE, NOT AVAILABLE FOR EVAL AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT, SPECIFIC MODEL OR LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. IT WAS REPORTED BY THE SURGEON THAT THE CATHETER HAD BEEN CUT BY DRESSING SCISSORS DURING REMOVAL. THE PT WAS TAKEN BACK TO THE OPERATING ROOM FOR CATHETER REMOVAL. IT WAS STATED THAT THE PT'S CONDITION WAS SATISFACTORY. THE DIRECTIONS FOR USE (DFU) PROVIDED WITH I-FLOW CATHETERS HAS A CAUTION: "DO NOT CUT OR FORCEFULLY REMOVE CATHETER." IF ADDITIONAL INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS CUT BY DRESSING SCISSORS DURING REMOVAL. THE PT WAS TAKEN BACK TO THE OPERATING ROOM FOR CATHETER REMOVAL. IT WAS STATED THAT THE PT'S CONDITION WAS SATISFACTORY. FOLLOW-UP WITH THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK INFUSION PUMP MEB I-FLOW CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R