BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVOY DISTAL ACCESS GUIDING CATHETER

    MDR report key: 2963748 · Received February 15, 2013

    Report

    Report Number
    1226348-2013-10007
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    DQY
    PMA / PMN Number
    K120229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS IS 2 OF MULTIPLE PRODUCTS INVOLVED WITH THIS EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 1226348-2013-10007 AND 1226348-2013-10008. PLEASE NOTE THAT THIS REPORT IS BEING RE-SUBMITTED BECAUSE THE ORIGINAL MEDWATCH REPORT SUBMITTED ON (B)(4) 2013 UNDER MANUFACTURER NUMBERS (3007628272-2013-50004/5) WERE REJECTED, BECAUSE THE MANUFACTURER NUMBER WAS NOT VALID. PLEASE SEE ATTACHMENTS FOR E-MAILS REGARDING THE ISSUE. . ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    PRIOR TO USE, THE 2 UNITS FOR A TOTAL OF 4UNITS 6FRENCH MULTIPURPOSE DA CATHETERS (67125805D/C10884X2-C10886-X2) WERE RECEIVED WITH YELLOW STICKERS THAT STATE NOT FOR HUMAN USE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67542 ENVOY DISTAL ACCESS GUIDING CATHETER CES GUIDING CATHETERS (DQY) DQY CODMAN AND SHURTLEFF, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1