BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAINBUSTER SILVERSOAKER LIN KIT 100 ML-HR

    MDR report key: 2230548 · Received August 12, 2011

    Report

    Report Number
    2026095-2011-00210
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 15, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LOT HISTORY FOUND NO OTHER COMPLAINTS FOR THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MFG SPECIFICATIONS PRIOR TO RELEASE. THE DIRECTIONS FOR USE (DFU), (1306078 REV. A) CONTAINS A WARNINNG: "DO NOT REINSERT A PARTIALLY OR COMPLETELY WITHDRAWN NEEDLE AS THIS CAN DAMAGE THE SHEATH AND BREAK OFF IN PT UPON SHEATH REMOVAL. FAILURE TO REMOVE INTRODUCER SHEATH FROM THE BODY BEFORE PEELING MAY RESULT IN A SEGMENT OF SHEATH BREAKING AND BEING RETAINED IN THE PT. THIS MAY LEAD TO INJURY". ONE UNUSED PUMP, ONE USED CATHETER, AND ONE USED SHEATH WERE RECEIVED FOR EVAL AND INVESTIGATION. THE PUMP AND THE CATHETER RETURNED WERE NOT EVALUATED AS THE COMPLAINT ISSUE WAS WITH THE SHEATH ONLY. THE VISUAL INSPECTION OF THE SHEATH (APPROX 3 INCHES LONG) SHOWS THAT IT WAS BROKEN AT BOTH ENDS. IT WAS NOTED THAT ONE SIDE OF THE SHEATH IS BROKEN/DISTORTED AND THE OTHER SIDE IS TORN/BROKEN. THE REMAINDER OF THE SHEATH WAS NOT RECEIVED. CONCLUSIONS: THE CUSTOMER COMPLAINT WAS CONFIRMED. NO DETERMINATION CAN BE MADE AS TO WHAT MAY HAVE OCCURRED WITH THIS PRODUCT.

    Description of Event or Problem · 1

    PROCEDURE: KNEE SCOPE. CATHPLACE: KNEE. SHEATH SPLIT DURING INSERTION, AND A PIECE BROKE OFF IN THE PT. INCISION WAS ENLARGED TO RETRIEVE THE PIECE. NEW SHEATH USED TO INSERT CATHETER. DATE OF EVENT: (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER SILVERSOAKER LIN KIT 100 ML-HR ELASTOMERIC PUMP MEB I-FLOW CORP. PM036-A 0C2849

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention