BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRELUDE SHORT SHEATH INTRODUCER IN CUSTOM KIT

    MDR report key: 1367188 · Received April 16, 2009

    Report

    Report Number
    1721504-2009-00060
    Event Type
    Malfunction
    Date Received
    April 16, 2009
    Date of Event
    April 7, 2009
    Report Date
    April 10, 2009
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DYB
    Removal / Correction Number
    1721504-04/10/09-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: DEVICE EVALUATION IS IN PROCESS. CONCLUSIONS: ALL SUBSEQUENT INVESTIGATION RESULTS WILL BE SUBMITTED TO THE FDA IN FOLLOW-UP MDR REPORTS, AND IN ACCORDANCE WITH STATUTORY PRODUCT RETRIEVAL REPORTING REQUIREMENTS.

    Description of Event or Problem · 1

    THIS IS TO INFORM FDA THAT MERIT MEDICAL SYSTEMS, INC. IS VOLUNTARILY RECALLING ALL PRELUDE SHORT SHEATH (PSS) INTRODUCERS MANUFACTURED BY MERIT MEDICAL SYSTEMS, INC. THE SIDEARM TUBING MAY DETACH FROM THE SHEATH DURING USE. IF THIS FAILURE OCCURS, IT MAY RESULT IN EXCESSIVE PATIENT BLOOD LOSS AND / OR RISK OF BLOOD-BORNE PATHOGEN EXPOSURE TO THOSE IN THE SURROUNDING AREA. MERIT HAS NOT BEEN INFORMED OF ANY PATIENT INJURIES; THE FAILURE RATE WAS IDENTIFIED THROUGH INTERNAL PRODUCTION INSPECTION AT A RATE OF APPROXIMATELY 1%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRELUDE SHORT SHEATH INTRODUCER IN CUSTOM KIT INTRODUCER, CATHETER DYB MERIT MEDICAL SYSTEMS, INC. NA V681838

    Patients

    Seq Age Sex Outcome Treatment
    1