BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 1733945 · Received June 18, 2010

    Report

    Report Number
    2026095-2010-00068
    Event Type
    Other
    Date Received
    June 18, 2010
    Date of Event
    May 21, 2010
    Report Date
    May 26, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE DEVICE WAS DISCARDED BY THE CUSTOMER AND IS THEREFORE NOT AVAILABLE FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND LOT HISTORY CANNOT BE REVIEWED. THE REPORTING PHYSICIAN INDICATED THAT NO FURTHER INFO WAS AVAILABLE. I-FLOW HAS 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). THE PT GUIDELINE INSERT, I-FLOW HAS PROVIDED CATHETER REMOVAL INSTRUCTIONS TO ENSURE SAFE REMOVAL (1305285M REV. C). THE DIRECTIONS FOR USE (DFU) (1306078, REV. D) CLEARLY PROVIDE CAUTIONS AND DIRECTIONS ON CATHETER REMOVAL IF RESISTANCE IS ENCOUNTERED. IT IS WORTH NOTING THAT I-FLOW'S CATHETERS ARE MADE OF A NON-TOXIC, MEDICAL-GRADE MATERIAL THAT MEETS ISO (B)(4) 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. 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 WHEN THE SURGEON WAS REMOVING THE CATHETER, THE SURGEON MET RESISTANCE, PULLED, AND THE CATHETER STRETCHED AND BROKE. THE SURGEON THREW OUT THE CATHETER, AND SEGMENT THAT BROKE HAD BEEN LEFT IN THE PT. A TECHNICAL BULLETIN WAS PROVIDED TO THE SURGEON BY THE CLINICAL HOTLINE. FOLLOW-UP WITH THE REPORTING DOCTOR INDICATED THAT THE PT WAS SEEN IN THE OFFICE ON (B)(6) 2010 AND THERE WERE NO UNTOWARD EFFECTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other