BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN PUMP WITH CATHETER

    MDR report key: 2555836 · Received April 27, 2012

    Report

    Report Number
    2026095-2012-00065
    Event Type
    Injury
    Date Received
    April 27, 2012
    Date of Event
    March 3, 2006
    Report Date
    April 5, 2012
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED FOR EVALUATION AND INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. RESULTS: THE INFORMATION CONTAINED IS FROM LEGAL DOCUMENTS SERVED ON I-FLOW CORPORATION. THE COMPLAINT WAS OPENED SO THAT A MEDICAL DEVICE REPORT (MDR) CAN BE FILED WITH THE US FOOD AND DRUG ADMINISTRATION. NO FURTHER INVESTIGATION WILL BE CONDUCTED. CONCLUSION: AS THIS COMPLAINT WAS CREATED FROM A LAWSUIT SERVED ON I-FLOW, NO CUSTOMER CONTACT CAN BE MADE AT THIS TIME DUE TO THE PENDING LITIGATION. AS OF (B)(4) 2006 I-FLOW HAS UPDATED ITS ON-Q PUMP DIRECTIONS FOR USE (DFU), TO INCLUDE THE FOLLOWING IN THE WARNINGS SECTION: "AVOID PLACING THE CATHETER IN JOINT SPACES. ALTHOUGH THERE IS NO DEFINITIVE ESTABLISHED CAUSAL RELATIONSHIP, SOME LITERATURE HAS SHOWN A POSSIBLE ASSOCIATION BETWEEN CONTINOUS INTRA-ARTICULAR INFUSIONS (PARTICULARLY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS." (DFU 1307011). ON (B)(4) 2007, I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY". (1303722, REV. E). THE DIRECTIONS FOR USE (DFU) (1307112, REV. A) 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 (1303971, REV. B) 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." IT IS NOT WORTH NOTING THAT I-FLOW'S CATHETERS ARE MADE OF A NON-TOXIC, MEDICAL-GRADE MATERIAL THAT MEETS (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.

    Description of Event or Problem · 1

    DRUG/DILUENT: UNKNOWN. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: RIGHT SHOULDER ARTHROSCOPIC SURGERY. CATHPLACE: GLENOHUMERAL JOINT. REFERENCE: 2026095-2012-00064 ((B)(4)). DURING REMOVAL, THE CATHETER BROKE LEAVING A PORTION OF THE CATHETER IN THE RIGHT GLENOHUMERAL JOINT. PT UNDERWENT SURGERY ON (B)(6), 2006, TO REMOVE THE REMAINING CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAIN PUMP WITH CATHETER ELASTOMERIC PUMP MEB I-FLOW CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other