BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMA 4 BRANCH 20MM PLATINUM GRAFT

    MDR report key: 2993065 · Received March 1, 2013

    Report

    Report Number
    2242352-2013-00182
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DSY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATIONS ARE COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A VASCULAR PROCEDURE, THE COLLAGEN COATING OF THE HEMASHIELD GRAFT APPEARED TO BE DISCOLORED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89259 HEMA 4 BRANCH 20MM PLATINUM GRAFT VASCULAR GRAFT DSY MAQUET CARDIOVASCULAR, LLC VS02175920P0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA