BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUSTOM KIT

    MDR report key: 1032574 · Received April 24, 2008

    Report

    Report Number
    1721504-2008-00027
    Event Type
    Other
    Date Received
    April 24, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 14, 2008
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    Removal / Correction Number
    1721504-04/14/08-005-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSIONS: IN 2008, MERIT DETERMINED THAT A PRODUCT RETRIEVAL WAS REQUIRED AFTER INTERNAL INVESTIGATION REVEALED THAT A SMALL NUMBER OF CONVENIENCE KITS SENT TO ONE U.S. CONSIGNEE AND ONE FOREIGN CONSIGNEE MAY BE NON-STERILE DUE TO VOIDS IN THE PACKAGE SEAL AREA. THERE HAVE BEEN NO ADVERSE EVENTS REPORTED THAT ARE ASSOCIATED WITH THIS RECALL. ALL SUBSEQUENT INVESTIGATION RESULTS WILL BE SUBMITTED TO THE FDA IN ACCORDANCE WITH STATUTORY PRODUCT RETRIEVAL REPORTING REQUIREMENTS.

    Description of Event or Problem · 1

    IN 2008, MERIT DETERMINED THAT A PRODUCT RETRIEVAL WAS REQUIRED AFTER INTERNAL INVESTIGATION REVEALED THAT A SMALL NUMBER OF CONVENIENCE KITS SENT TO ONE U.S. CONSIGNEE AND ONE FOREIGN CONSIGNEE MAY BE NON-STERILE DUE TO VOIDS IN THE PACKAGE SEAL AREA. PLEASE NOTE THAT THERE HAVE BEEN NO ADVERSE EVENTS REPORTED THAT ARE ASSOCIATED WITH THIS RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. NA F603790

    Patients

    Seq Age Sex Outcome Treatment
    1