BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 1030553 · Received April 17, 2008

    Report

    Report Number
    2026095-2008-00034
    Event Type
    Other
    Date Received
    April 17, 2008
    Date of Event
    February 1, 2008
    Report Date
    March 18, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR EVAL AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT OR A LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED THAT A PT HAD SURGERY IN 2007. AFTER COMPLAINING OF PAIN, THE PT EXPRESSED A PIECE OF PLASTIC FROM THE CATHETER SITE. IT WAS IDENTIFIED BY THE SURGEON AS THE PLASTIC FROM THE WHITE INTRODUCER. THIS MOST LIKELY HAD BROKEN OFF DURING REMOVAL DURING THE 2007 SURGERY. THE DFU CONTAINS BOTH A WARNING AND A CAUTION CONCERNING SHEATH BREAKAGE. THE WARNING STATES: "DO NOT REINSERT A PARTIALLY OR COMPLETELY WITHDRAWN NEEDLE AS THIS CAN DAMAGE THE SHEATH AND BREAK OFF IN PT UPON SHEATH REMOVAL." THE CAUTION STATES: "WHILE HOLDING CATHETER TIP (1), WITHDRAW SHEATH COMPLETELY FROM PUNCTURE SITE PRIOR TO SPLITTING TO AVOID SHEATH BREAKING OFF IN PT." IF ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    PT WITH CROHN'S DISEASE UNDERWENT AN ILEOCECAL RESECTION THE LATER PART OF LAST YEAR. SHE WAS FOLLOWED IN CLINIC APPROX FOUR MONTHS LATER AND COMPLAINED OF PAIN NEAR THE DRAINAGE SITE. SHE HAD EXPRESSED A PIECE OF PLASTIC FROM THE SITE WHERE HER PAIN BALL WENT IN. THE SURGEON EXAMINED THE PLASTIC PIECE, AND IT APPEARED TO BE A TORN PIECE OF WHITE INTRODUCER MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER INFUSION PUMP MEB I-FLOW CORP. PM023-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention