BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMA 4 BRANCH 24MM PLATINUM GRAFT

    MDR report key: 2833232 · Received October 26, 2012

    Report

    Report Number
    2242352-2012-01157
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    MAL
    PMA / PMN Number
    K021213
    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 NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS REC'D. 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 ON THE HEMASHIELD PLATINUM GRAFT APPEARED MELTED OR STAINED UPON OPENING THE PACKAGE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL INTENDS TO RETURN THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMA 4 BRANCH 24MM PLATINUM GRAFT VASCULAR GRAFT MAL MAQUET CARDIOVASCULAR, LLC 175924P 25058762

    Patients

    Seq Age Sex Outcome Treatment
    1 NA