BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN PUMP

    MDR report key: 4788175 · Received May 21, 2015

    Report

    Report Number
    2026095-2015-00152
    Event Type
    Injury
    Date Received
    May 21, 2015
    Date of Event
    April 1, 2013
    Report Date
    April 30, 2015
    Manufacturer
    HALYARD SALES, LLC
    Product Code
    MEB
    PMA / PMN Number
    PK063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE PRODUCT WAS NOT RETURNED FOR AN EVALUATION AND INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) CANNOT BE PERFORMED. RESULTS: THE INFORMATION CONTAINED IS FROM LEGAL DOCUMENTS SERVED ON I-FLOW, LLC.. PURSUANT TO A TRANSACTION FILED WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION, THE HEALTH CARE BUSINESS OF KIMBERLY-CLARK (WHICH INCLUDED THE BUSINESS OF ITS WHOLLY-OWNED SUBSIDIARY, I-FLOW, LLC), WAS SPUN OFF AND IS NOW HALYARD. 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. CONCLUSIONS: 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)(6) 2006, I-FLOW 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 CONTINUOUS INTRA-ARTICULAR INFUSIONS (PARTICULARLY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS." (DFU 1307011). ON (B)(6) 2007, I-FLOW ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY". (1303722, REV. E). INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    FILL VOLUME: NI FLOW RATE: NI PROCEDURE: ARTHROSCOPIC LABRAL RECONSTRUCTION AND CAPSULORRHAPHY ON THE RIGHT SHOULDER SURGERY CATHPLACE: INTRA-ARTICULAR JOINT SPACE - RIGHT SHOULDER PATIENT ALLEGES CHONDROLYSIS IN SHOULDER FOLLOWING PLACEMENT OF AN ON-Q PUMP AFTER SURGERY ON OR ABOUT (B)(6) 2008. ON (B)(6) 2013, THE PATIENT COMPLAINED OF RIGHT SHOULD PAIN AND STIFFNESS WITH THE PATIENT TAKING (B)(6) AND NAPROSYN WITH MILD RELIEF. THE PATIENT HAD AN INJECTION OF LIDOCAINE AND KENALOG TO THE RIGHT GLENOHUMERAL JOINT. THE PATIENT WAS SUBSEQUENTLY DIAGNOSED WITH CHONDROLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332909 ON-Q PAIN PUMP ELASTOMERIC PUMP MEB HALYARD SALES, LLC UNKNOWN ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other KEFLEX| PERCOCET| 0.25% MARCAINE