BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PLUERAL AIR LEAK SEALANT

    MDR report key: 5363139 · Received January 13, 2016

    Report

    Report Number
    1213643-2016-00013
    Event Type
    Malfunction
    Date Received
    January 13, 2016
    Date of Event
    November 27, 2015
    Report Date
    December 14, 2015
    Manufacturer
    NEOMEND INC
    Product Code
    NBE
    PMA / PMN Number
    P010047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT PRODUCT WAS NOT RETURNED FOR EVALUATION. PHOTOGRAPHS OF THE SUBJECT PRODUCT WERE PROVIDED BY THE USER FACILITY. THE PHOTOGRAPHS DEPICT A FRAGMENT SHOWN OUTSIDE THE APPLICATOR LYING IN THE TRAY. AS REPORTED, THE FRAGMENT WAS NOTED ON THE LUNG DURING THE CASE AND WAS REMOVED. IT APPEARS THAT THE FRAGMENT IS A BROKEN FRAGMENT OF THE GLASS VIAL. EXAMINATION OF THE PROXIMAL END OF THE APPLICATOR, WHERE THE VIALS ARE PUSHED IN, SHOWS AN AREA THAT APPEARS TO BE ONE OF THE GLASS VIALS INSIDE THE APPLICATOR WITH A PIECE MISSING. THERE WERE NO SIGNS OF DAMAGE TO THE PUSH ROD NOTED. A MANUFACTURING REVIEW WAS CONDUCTED FOR THIS LOT SHOWING THE DEVICE MET SPECIFICATION WHEN RELEASED TO STOCK. A DEFINITIVE CONCLUSION AT THIS TIME AS TO WHEN AND HOW THE VIALS WERE DAMAGED CANNOT BE REACHED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. NOTE:THE USER FACILITY NUMBER AS REPORTED ((B)(4)) MAY NOT BE CORRECT AS IT WOULD NOT ACCEPT THROUGH EMDR GATEWAY. DEVICE RETAINED BY RISK MANAGEMENT AT THE USER FACILITY.

    Description of Event or Problem · 1

    INFORMATION AS RECEIVED BY THE USER FACILITIES MDR: "(B)(6) YR OLD FEMALE PT IN THE OR FOR A LEFT LOWER LOBE RESECTION, AT THE END OF THE CASE THE RAW EDGE OF THE LUNG WAS SPRAYED WITH SURGICEL FOR ANY SMALL AIR LEAKS OF THE RAW SURFACE OF THE LUNG. DURING CLOSING A SMALL PIECE OF BROKEN PLASTIC WAS LYING ON THE LUNG. FURTHER INSPECTION SHOWED THAT THIS HAD OBVIOUSLY COME OFF THE BACK OF THE PROGEL INJECTOR. THE TUBE HAD ACTUALLY BROKEN INTO 2 PIECES, EACH APPROXIMATELY 2X3MM. ONLY ONE PIECE WAS FOUND. THE PT WAS VERY THIN AND EXCELLENT VIEWS OF THE ENTIRE THORACIC CAVITY WERE HAD. IRRIGATION WAS USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21659 PROGEL PLUERAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC 150817-002

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR