BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PLUERAL AIR LEAK SEALANT

    MDR report key: 5202208 · Received November 4, 2015

    Report

    Report Number
    1213643-2015-00368
    Event Type
    Malfunction
    Date Received
    November 4, 2015
    Date of Event
    October 9, 2015
    Report Date
    October 9, 2015
    Manufacturer
    NEOMEND INC
    Product Code
    NBE
    PMA / PMN Number
    P010047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT PRODUCT WAS RETURNED FOR EVALUATION AND VISUALLY INSPECTED. THE PEG GLASS CARTRIDGE AND THE ALBUMIN GLASS CARTRIDGE WERE BOTH RECEIVED PHYSICALLY FRACTURED. THERE WERE NO SIGNS OF DAMAGE TO THE PUSH ROD OR OTHER COMPONENTS. A DIMENSIONAL INSPECTION OF THE VIALS FOUND NO ANOMALIES. MANUFACTURING REVIEW WAS CONDUCTED FOR THIS LOT SHOWING THE DEVICE MET SPECIFICATION WHEN RELEASED TO STOCK. THE BROKEN FRAGMENTS WERE NOT RETURNED BUT IT WAS INITIALLY REPORTED THAT SOME GLASS MATERIAL WAS NOTED IN THE PRODUCT TRAY INDICATING THAT THE GLASS VIALS WERE DAMAGED WITHIN THE PACKAGING. IT IS NOT LIKELY THAT PERSONS HANDLING THE PRODUCT IN THE KIT ASSEMBLY PROCESS WOULD NOT DETECT PHYSICALLY FRACTURE VIALS. THEREFORE WE CANNOT REACH A DEFINITIVE CONCLUSION AT THIS TIME AS TO WHEN AND HOW THE VIALS WERE DAMAGED.

    Description of Event or Problem · 1

    INFORMATION AS REPORTED TO DAVOL: IT WAS REPORTED THAT WHEN THE PROGEL WAS OPENED FOR USE IN A ROBOTIC LOBECTOMY, IT WAS NOTICED THAT THE GLASS VILE THAT THE PEG COMPOUND CAME IN WAS BROKEN AND THERE WERE LITTLE PIECES OF GLASS IN THE BOTTOM. AN ATTEMPT TO USE THE PRODUCT WAS MADE BECAUSE THE VIAL DIDN'T LOOK BROKEN INITIALLY AND THE PROGEL LEAKED OUT OF THE VIAL UPON LOADING INTO APPLICATOR HOUSING. THE OUTSIDE PACKAGING WAS NOT REPORTED TO BE DAMAGED. ANOTHER PROGEL WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT/USER INJURY AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732796 PROGEL PLUERAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC 150826-001

    Patients

    Seq Age Sex Outcome Treatment
    1