BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO OUS

    MDR report key: 1579988 · Received January 14, 2010

    Report

    Report Number
    2648729-2009-00037
    Event Type
    Injury
    Date Received
    January 14, 2010
    Date of Event
    December 17, 2009
    Report Date
    December 17, 2009
    Manufacturer
    MAQUET PUERTO RICO, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOVASCULAR RECEIVED THE DEVICE ON 01/13/2010. QUALITY WILL EVALUATE THE DEVICE AND PERFORM INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. NOTE - THE HOSPITAL REPORTED A LOT NUMBER (9060871) THAT DOES NOT EXIST FOR THE REPORTED DEVICE. THEREFORE, THERE IS NO INFORMATION FOR THE EXPIRATION AND PRODUCTION DATES.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE DISSECTION TIP FROM A HEMOPRO KIT BROKE IN THE PATIENT'S LEG. THE PIECE WAS RETRIEVED USING THE C-RING. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE HOSPITAL DID NOT REPORT ANY PATIENT COMPLICATIONS. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO OUS DISSECTION TIP FROM VV HEMOPRO-OUS GEI MAQUET PUERTO RICO, LLC VH-3000-W 9060871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention