BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHORT PORT BTT SURGICAL PORT AND SYRINGE

    MDR report key: 2013273 · Received March 8, 2011

    Report

    Report Number
    2242352-2011-00118
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 7, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K030512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A VISUAL INSPECTION REVEALED THE SILICON AND LATEX HAD BURST. THE SUTURE HAD SHIFTED. THERE WAS SOME EVIDENCE OF BLOOD. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT "BALLOON RUPTURED" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SHORT PORT RUPTURED. A REPLACEMENT UNIT WAS USED TO COMPETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHORT PORT BTT SURGICAL PORT AND SYRINGE SHORT PORT BTT GCJ MAQUET CARDIOVASCULAR, LLC 13005 25011721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other