BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRELUDE SHORT SHEATH INTRODUCER

    MDR report key: 1367165 · Received April 16, 2009

    Report

    Report Number
    1721504-2009-00052
    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: OTHER, EVALUATION IS IN PROCESS. EVALUATION: 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. PER DIRECTION FROM REP OF THE DISTRICT OFFICE IN 2009, REPORTS ARE BEING SUBMITTED FOR EACH PRODUCT CODE. ADD'L LOT NUMBER: F635036, EXPIRATION DATE: 09/17/2011, MANUFACTURE DATE: 09/2008; LOT NUMBER: F661572, EXPIRATION DATE: 11/21/2011, MANUFACTURE DATE: 11/2008; LOT NUMBER: F680288, EXPIRATION DATE: 03/22/2012, MANUFACTURE DATE: 03/2009; LOT NUMBER: F686779, EXPIRATION DATE: 03/31/2012, MANUFACTURE DATE: 03/2009.

    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 SYSTEM, INC. THE SIDEARM TUBING MAY DETACH FROM THE SHEATH DURING USE. IF THIS FAILURE OCCURS, IT MAY RESULT IN EXCESSIVE PT BLOOD LOSS AND / OR RISK OF BLOOD-BORNE PATHOGEN EXPOSURE TO THOSE IN THE SURROUNDING AREA. MERIT HAS NOT BEEN INFORMED OF ANY PT 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 INTRODUCER, CATHETER DYB MERIT MEDICAL SYSTEMS, INC. NA F620906

    Patients

    Seq Age Sex Outcome Treatment
    1