BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS SHEATH INTRODUCER SET

    MDR report key: 3770630 · Received April 24, 2014

    Report

    Report Number
    2015691-2014-00935
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 27, 2014
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DQY
    PMA / PMN Number
    K831729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED AN OPEN INTRODUCER TRAY WITH ONLY THE SCALPEL AND DILATOR INSIDE FOR EXAMINATION. EXAMINATION OF THE PACKAGE FOUND WHAT APPEARED TO BE A HAIR/FIBER LIKE SAMPLE. THE SAMPLE WAS REMOVED PHOTOGRAPHED AND WAS SENT TO CHEMISTRY FOR TESTING. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WITH CHEMISTRY RESULTS AND THE DEVICE HISTORY REVIEW.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. CHEMISTRY TESTING FOUND THE SUBSTANCE SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARED TO PROTEIN LIKE MATERIAL.

    Description of Event or Problem · 1

    AS REPORTED, WHEN PERCUTANEOUS SHEATH INTRODUCER SET WAS OPENED, THERE WAS ONE HAIR FOUND IN THE SET. THEREFORE, THE SET WAS NOT USED ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249888 PERCUTANEOUS SHEATH INTRODUCER SET CATHETER, PERCUTANEOUS DQY EDWARDS LIFESCIENCES PR I350BF85 59655057

    Patients

    Seq Age Sex Outcome Treatment
    1