BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q CATHETER

    MDR report key: 2210352 · Received August 9, 2011

    Report

    Report Number
    2026095-2011-00208
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    April 2, 2011
    Report Date
    July 12, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIRECTIONS FOR USE (DFU) (1306078, REV. D) 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 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." (1303971, REV. B). 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. RESULTS: DEVICE WAS RECEIVED FOR EVALUATION AND INVESTIGATION, AND TESTING IS CURRENTLY BEING PERFORMED. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DRUG/DILUENT: MARCAIN PLAIN 0.55 PERCENT. FILL VOLUME: 270ML. FLOW RATE: 4ML/HR. PROCEDURE: ABDOMINOPLASTY. CATHPLACE: BILATERAL AND PARALLEL TO MIDLINE. DATE OF SURGERY: (B)(6), 2011. CATHETER BROKE DURING REMOVAL BY PATIENT. SURGEON DID NOT HAVE DIFFICULTY INSERTING THE CATHETER OR REMOVING THE INTRODUCER. CATHETER APPEARED STRETCHED AT THE BREAK POINT AND APPROXIMATELY 5 INCHES WAS LEFT IN THE PATIENT. CATHETER FRAGMENT HAS NOT BEEN REMOVED FROM PATIENT. PER SURGEON ON (B)(6), 2011, PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q CATHETER CATHETER BSO I-FLOW CORP. UNK ANP

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other