BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTRODUCER NEEDLE

    MDR report key: 1342076 · Received March 5, 2009

    Report

    Report Number
    2026095-2009-00045
    Event Type
    Other
    Date Received
    March 5, 2009
    Date of Event
    February 9, 2009
    Report Date
    February 10, 2009
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS AVAILABLE FOR EVALUATION AND INVESTIGATION. IT WAS REPORTED THAT THE SHEATH BROKE DURING REMOVAL, AND THE SEGMENTS WERE DISCARDED. WITHOUT THE ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. THE DIRECTIONS FOR USE CONTAINS FOR THE SHEATH WHICH STATES: "WHILE HOLDING CATHETER TIP, WITHDRAW SHEATH COMPLETELY FROM PUNCTURE SITE PRIOR TO SPLITTING TO AVOID SHEATH BREAKING OFF IN PATIENT. SPLIT SHEATH AND PEEL AWAY FROM CATHETER." A WARNING IS ALSO INCLUDED, STATING "DO NOT REINSERT A PARTIALLY OR COMPLETELY WITHDRAWN NEEDLE AS THIS CAN DAMAGE THE SHEATH AND BREAK OFF IN PATIENT UPON SHEATH REMOVAL." NO DETERMINATION CAN BE MADE AS TO WHAT MAY HAVE OCCURED WITH THIS PRODUCT AT THIS TIME. IF ADDITIONAL INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL REOPEN THE COMPLAINT.

    Description of Event or Problem · 1

    SHEATH BROKE WHILE BEING REMOVED FROM PATIENT. DISCARDED PIECES AFTER REMOVAL FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRODUCER NEEDLE INTRODUCER NEEDLE DYB I-FLOW CORPORATION PM025 6A2490

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other