BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARVIEW BLOWER/MISTER

    MDR report key: 1971375 · Received January 7, 2011

    Report

    Report Number
    2135394-2011-00002
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    FQH
    PMA / PMN Number
    K973485
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION SHOWED THE BLUE TIP OF THE DEVICE WAS MISSING FROM THE DISTAL END. FURTHER INSPECTION OF THE GRIT BLAST SURFACE, SHOWED NO EVIDENCE OF BONDING RESIDUE. THE PRODUCT HAS BEEN SENT TO THE CONTRACT MFR FOR FURTHER ANALYSIS. CONCLUSION: THE CAUSE OF THIS DEVICE COULD NOT BE DETERMINED AT THIS TIME. SHOULD FURTHER INFO BE PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS CANNULA'S BLUE TIP BROKE OFF DURING USE. THE TIP HAS NOT BEEN FOUND. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARVIEW BLOWER/MISTER FQH MEDTRONIC PERFUSION SYSTEMS 22150 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R