BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAINBUSTER SOAKER 6.5, 270ML VOL X 5 ML/HR

    MDR report key: 2210540 · Received August 10, 2011

    Report

    Report Number
    2026095-2011-00217
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    June 7, 2006
    Report Date
    July 14, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED FOR EVALUATION AND INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RESULTS: THE ON-Q PUMP DIRECTIONS FOR USE (DFU) CONTAIN A WARNING THAT STATES: "AVOID PLACING THE CATHETER IN JOINT SPACES. ALTHOUGH THERE IS NO DEFINITIVE ESTABLISHED CAUSAL RELATIONSHIP, SOME LITERATURE HAS SHOWN A POSSIBLE ASSOCIATION BETWEEN CONTINUOUS INTRA-ARTICULAR INFUSIONS (PARTICULARLY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS." (B)(4). I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY". (B)(4). IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    DRUG/DILUENT: MARCAINE 0.5%. FILL VOLUME: UNK. FLOW RATE: UNK. PROCEDURE: ARTHROSCOPIC SURGERY. CATHPLACE: RIGHT SHOULDER JOINT. PATIENT ALLEGEDLY DEVELOPED GLENOHUMERAL CHONDROLYSIS FOLLOWING PLACEMENT OF AN ON-1 PAINBUSTER PUMP AFTER SURGERY ON (B)(6) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER SOAKER 6.5, 270ML VOL X 5 ML/HR ELASTOMERIC PUMP MEB I-FLOW CORP. PM014 642402

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other