BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONARY CONTROL SYRINGE

    MDR report key: 1833058 · Received September 10, 2010

    Report

    Report Number
    1721504-2010-00276
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 1, 2010
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    FMF
    PMA / PMN Number
    K024052
    Removal / Correction Number
    1721504-9/15/10-005-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS NOT BEEN RECEIVED FOR EVAL/INVESTIGATION. MERIT DETERMINED ON 09/03/2010 THAT A PRODUCT REMOVAL WOULD BE REQUIRED FOR SIX (6) SPECIFIC LOTS FOR SIX (6) SPECIFIC CATALOG CODES OF THE CORONARY CONTROL SYRINGES (CCS/CCX) BECAUSE THERE MAY BE SMALL HOLES IN THE PACKAGE WHICH MAY RENDER THE PRODUCT NON-STERILE. THIS IS A 5-DAY MDR REPORT IN ACCORDANCE WITH STATUTORY REPORTING REQUIREMENTS. COMMUNICATIONS TO DOMESTIC CONSIGNEES WAS SENT ON 09/09/2010, COMMUNICATIONS TO INTERNATIONAL CONSIGNEES WAS SENT ON 09/10/2010. A REPORT TO THE FDA IN ACCORDANCE WITH 21 CFR 806.10 IS ALSO IN PROCESS. NO ADDITIONAL FORM 3500A REPORTS WILL BE FILED FOR THIS EVENT. NOTIFICATION OF FIELD ACTION TAKEN.

    Description of Event or Problem · 1

    DISTRIBUTOR NOTED AT RECEIVING INSPECTION, THERE IS A HOLE IN THE CORNER OF THE LETTER '2' THAT IS STAMPED ON THE CLEAR FILM OF THE POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORONARY CONTROL SYRINGE SYRINGE, PISTON FMF MERIT MEDICAL SYSTEMS, INC. H137552

    Patients

    Seq Age Sex Outcome Treatment
    1 Other