BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLP PEDIATRIC CANNULA - 18 FR

    MDR report key: 1631236 · Received March 10, 2010

    Report

    Report Number
    2184009-2010-00002
    Event Type
    Injury
    Date Received
    March 10, 2010
    Date of Event
    February 12, 2010
    Report Date
    February 12, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K040173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). DEVICE HISTORY REVIEW IS PENDING. NO DEVICE HAS BEEN RETURNED FOR ANALYSIS YET. RESULTS CODE: DEVICE HISTORY REVIEW IS PENDING. NO DEVICE HAS BEEN RETURNED FOR ANALYSIS YET. CAUSE OF EVENT CANNOT BE DETERMINED. NO PRODUCT HAS BEEN RETURNED FOR ANALYSIS. CONCLUSION: THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED AT THIS TIME. IT IS EXPECTED THAT PRODUCT WILL BE RETURNED. ONCE ANALYSIS AND FURTHER INVESTIGATION HAS BEEN COMPLETED, THIS EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MEDTRONIC (B) (4) RECEIVED INFORMATION THAT AFTER COMING OFF BYPASS, THIS ROOT CANNULA WAS BEING TAKEN OUT. THE BLUE TIP OF THE CANNULA FELL OFF INTO THE PATIENT'S CHEST AND HAD TO BE PICKED OUT BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DLP PEDIATRIC CANNULA - 18 FR DWF MEDTRONIC PERFUSION SYSTEMS 12218 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention