BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DLP SINGLE STAGE VENOUS CANNULA

    MDR report key: 2140581 · Received June 16, 2011

    Report

    Report Number
    2184009-2011-00038
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 17, 2011
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K842375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD, RESULTS: OTHER - DEVICE HISTORY REVIEW IS PENDING. NO PRODUCT HAS BEEN RETURNED. CONCLUSION: OTHER - CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT HAS BEEN RETURNED FOR ANALYSIS, AND THE DEVICE HISTORY REVIEW IS PENDING. CONCLUSION: BASED ON THE AVAILABLE INFORMATION, THE CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. UPON RECEIPT OF ADDITIONAL INFORMATION OR PRODUCT RETURN, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS CANNULA EXHIBITED A SPLIT WHEN A SUTURE WAS TIED ONTO THE CANNULA BODY. IT WAS REPORTED THAT THIS EVENT OCCURRED AS A RESULT OF THE CHIEF PERFUSIONIST TESTING THE CANNULA'S DURABILITY OFF THE SHELF IN RESPONSE TO AN ADVERSE EVENT THAT OCCURRED DAYS PRIOR (MANUFACTURER REPORT NUMBER 2184009-2011-00037).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DLP SINGLE STAGE VENOUS CANNULA DWF MEDTRONIC PERFUSION SYSTEMS 69328 2011030547

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other