BEUDAMED
    FDA Adverse Event Other Summary report: N

    TUNNELER, DISPOSABLE

    MDR report key: 1012998 · Received March 12, 2008

    Report

    Report Number
    2026095-2008-00016
    Event Type
    Other
    Date Received
    March 12, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 11, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE SAMPLE FOR THE INVESTIGATION HAS BEEN RECEIVED FOR EVAL. THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER AND THE EVAL OF THE SAMPLE. THE REPORT STATED THAT A PORTION OF THE SHEATH HAD BROKEN OFF WHILE BEING PEELED AWAY FROM THE INTRODUCER. THE BROKEN SEGMENT WAS REMOVED ENTIRELY USING HEMOSTATS. THE SHEATH SUBMITTED FOR EVAL WAS BROKEN ALMOST IN HALF AND THE SEPARATED SECTION OF THE SHEATH WAS STRETCHED. IT WAS REPORTED THAT THE SHEATH WAS BEING PEELED AND REMOVED SIMULTANEOUSLY, WHICH IS CONTRARY TO THE DIRECTIONS FOR USE (DFU). 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 THE WARNING STATES: "DO NOT REINSERT A PARTIALLY OR COMPLETELY WITHDRAWN NEEDLE AS THIS CAN DAMAGE THE SHEATH AND BREAK OFF IN PT UPON SHEATH REMOVAL."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 SPITTING TO AVOID SHEATH BREAKING OFF IN PT." IF ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAIL, I-FLOW WILL SUBMIT A F/U REPORT.

    Description of Event or Problem · 1

    WHILE THE PHYSICIAN ASSISTANT WAS REMOVING THE SHEATH, WHILE PEELING IT AWAY, A PORTION OF THE SHEATH BROKE OFF IN THE MUSCLE. PA WAS ABLE TO REMOVE ALL PARTS OF THE SHEATH. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUNNELER, DISPOSABLE TUNNELER DYB I-FLOW CORP. T17X8 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention