BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q CATHETER

    MDR report key: 2142118 · Received May 26, 2011

    Report

    Report Number
    2026095-2011-00148
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO SAMPLE WAS RETURNED FOR EVAL AND INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 SYS." (1303971, REV. B). THE PT GUIDELINE INSERT, I-FLOW HAS PROVIDED CATHETER REMOVAL INSTRUCTIONS TO ENSURE SAFE REMOVAL (1305285, REV. D). THE DIRECTIONS FOR USE (DFU) (1306078, REV. D) PROVIDE CAUTIONS AND DIRECTIONS ON CATHETER REMOVAL IF RESISTANCE IS ENCOUNTERED. RESULTS: THE DEVICE WAS DISCARDED. WITHOUT THE SAMPLE, LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. IF ADD'L INFO PERTINENT TO THIS COMPLAINT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A F/U REPORT.

    Description of Event or Problem · 1

    DRUG/DILUENT: MARCAINE PLAIN 0.5%. FILL VOLUME: 270ML & FLOW RATE: 5ML/HR. PROCEDURE: RIGHT ABOVE KNEE AMPUTATION. CATHPLACE: RIGHT STUMP. CATHETER BROKE INSIDE THE PT DURING REMOVAL. PT HAD KNEE SURGERY ON (B)(6) 2011. CATHETER WAS REMOVED ON (B)(6) 2011 AND DURING REMOVAL, IT BROKE, HOWEVER, THE FRAGMENT WAS REMOVED AS WELL ON THAT DATE. CATHETER AND PUMP WERE ON-Q (PUMP WAS A 270ML, 5ML/HR PUMP) BUT NEITHER WAS SAVED FOR RETURN. THESE ITEMS WERE NOT RETURNED WHEN THE PT CAME BACK FOR THE CATHETER REMOVAL. DATE OF EVENT: (B)(6), 2011. ANP: ASKED BUT NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR