BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q CATHETER

    MDR report key: 1346157 · Received March 13, 2009

    Report

    Report Number
    2026095-2009-00055
    Event Type
    Other
    Date Received
    March 13, 2009
    Date of Event
    February 12, 2009
    Report Date
    February 13, 2009
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR EVAL AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT, PART NUMBER, OR LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONCLUDED. 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). ALSO, IN THE PT GUIDELINE INSERT, I-FLOW HAS PROVIDED CATHETER REMOVAL INSTRUCTIONS TO ENSURE SAFE REMOVAL (1305285, REV. C). 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 THE PT REMOVED THE CATHETER AND DISPOSED OF THE DEVICE. THE PT READ THE PT GUIDELINES THE FOLLOWING DAY AND SAW THAT HE WAS TO HAVE A BLACK TIP AT THE END. THE PT DID NOT SEE A BLACK TIP; HOWEVER, DID SEE OTHER MARKINGS. THE PT WAS ADVISED TO RETRIEVE PUMP IF POSSIBLE AND CALL PHYSICIAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other