BEUDAMED
    FDA Adverse Event Other Summary report: N

    TUNNELER

    MDR report key: 1649185 · Received March 24, 2010

    Report

    Report Number
    2026095-2010-00026
    Event Type
    Other
    Date Received
    March 24, 2010
    Date of Event
    December 10, 2009
    Report Date
    February 26, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    K063234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. FOLLOW-UP WITH HOSPITAL RISK MGR INDICATED THAT THE ADVERSE EVENT IS ATTRIBUTED TO USER ERROR AND THERE WAS NO DEVICE MALFUNCTION. THE DEVICES ARE NOT AVAILABLE FOR EVAL. THE REPORT LISTS TUNNELER MODEL T16X12, WHICH WOULD BE PRESUMED TO BE THE DEVICE USED TO INSERT ON-Q SILVER SOAKER CATHETER SIZES (5") AND (7.5") FOR PAIN CONTROL. THE TUNNELER IS BLUNT TIPPED AND IS INDICATED FOR PERCUTANEOUS PLACEMENT OF ON-Q CATHETERS. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND THE LOT HISTORY CANNOT BE REVIEWED. 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

    IT WAS REPORTED THAT ON-Q SILVERSOAKER CATHETER SIZES (5") AND (7.5") WERE INSERTED ON (B) (6) 2009 FOR PAIN CONTROL. ON (B) (6) 2009, PT WENT TO OPERATING ROOM FOR A PERFORATED BOWEL. THE SURGEON NOTED CATHETERS IN THE BOWEL. TUNNELER MODEL T16X12 WAS IDENTIFIED IN THE HOSPITAL'S MEDWATCH REPORT, WHICH IS PRESUMED TO BE THE DEVICE USER TO INSERT THE CATHETERS. FOLLOW-UP WITH HOSPITAL RISK MANAGER INDICATED THAT THE ADVERSE EVENT IS ATTRIBUTED TO USER ERROR AND THERE WAS NO DEVICE MALFUNCTION. THE DEVICES ARE NOT AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUNNELER TUNNELER BSO I-FLOW CORP. T16X12 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening