BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER

    MDR report key: 2520445 · Received April 4, 2012

    Report

    Report Number
    2026095-2012-00053
    Event Type
    Injury
    Date Received
    April 4, 2012
    Report Date
    March 13, 2012
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    BSO
    PMA / PMN Number
    K043456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSIONS: IF ADD'L INFO PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A F/U REPORT. I-FLOW PROVIDED A STATEMENT UNDER THE DIRECTIONS FOR USE (DFU) (1307112, REV. A) PROVIDE CAUTIONS AND DIRECTIONS ON CATHETER REMOVAL IF RESISTANCE IS ENCOUNTERED. IT ALSO CONTAINS A CAUTION OF "DO NOT CUT OR FORCEFULLY REMOVE CATHETER." I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN (1303971, REV. B) IN ORDER TO PREVENT OR DECREASE CATHETER BREAKS ENTITLED: "TIPS FOR PREVENTING IN-SITU CATHETER BREAKAGE WITH THE ON-Q POST-OP PAIN RELIEF SYSTEM." IT IS WORTH NOTING THAT I-FLOW'S CATHETERS ARE MADE OF A NON-TOXIC, MEDICAL-GRADE MATERIAL THAT MEETS ISO 10993-1 TISSUE COMPATIBILITY GUIDELINES FOR IMPLANTATION OF UP TO 30-DAYS; COMPLICATIONS MAY ARISE IF A CATHETER (OR PORTION THEREOF) IS LEFT IN THE BODY FOR LONGER THAN THIS PERIOD OF TIME.

    Description of Event or Problem · 1

    DRUG/DILUENT: UNK; FILL VOLUME: UNK; FLOW RATE: UNK; PROCEDURE: UNK; CATHPLACE: UNK. IT WAS REPORTED A 15CM CATHETER HAS BEEN FOUND IN A PT WEEKS AFTER THE SURGERY AND HAD AN INFECTION. THE HOSPITAL IS NOT WILLING TO PROVIDE ANY DETAILS UNTIL THE HOSPITAL RISK MANAGEMENT REVIEWS THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER ANASTHESIA CONDUCTION CATHETER BSO I-FLOW CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other