BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PLATINUM PLEURAL AIR LEAK SEALANT

    MDR report key: 19519080 · Received June 12, 2024

    Report

    Report Number
    1213643-2024-00300
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 21, 2024
    Report Date
    July 1, 2024
    Manufacturer
    NEOMEND INC -2953195
    Product Code
    NBE
    UDI-DI
    00801741010040
    PMA / PMN Number
    P010047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE PROGEL PLATINUM CARTRIDGE BROKEN WHEN PRESS THE SYRINGE'S PUSH ROD. THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE PHOTOS PROVIDED CANNOT CONFIRM THE GLASS BREAK AS REPORTED. BASED ON THE INFORMATION PROVIDED AND WITHOUT HAVING THE SAMPLE TO EVALUATE, NO CONCLUSIONS CAN BE MADE. REVIEW OF MANUFACTURING RECORDS SHOWS PRODUCT WAS MADE TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION IN AUGUST 2023. THE SUBJECT PRODUCT PROGEL PLATINUM IS NOT MARKETED FOR US SALES. A SIMILAR PRODUCT PROGEL IS MARKETED IN THE US. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE PROGEL PLATINUM CARTRIDGE BROKEN WHEN PRESS THE SYRINGE'S PUSH ROD. THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE PHOTOS PROVIDED CANNOT CONFIRM THE GLASS BREAK AS REPORTED. BASED ON THE INFORMATION PROVIDED AND WITHOUT HAVING THE SAMPLE TO EVALUATE, NO CONCLUSIONS CAN BE MADE. REVIEW OF MANUFACTURING RECORDS SHOWS PRODUCT WAS MADE TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION IN AUGUST 2023. THE SUBJECT PRODUCT PROGEL PLATINUM IS NOT MARKETED FOR US SALES. A SIMILAR PRODUCT PROGEL IS MARKETED IN THE US. ADDENDUM: THIS SUPPLEMENTAL MDR IS SUBMITTED TO DOCUMENT THE SAMPLE EVALUATION RESULTS. EVALUATION OF THE SAMPLE CONFIRMS A BROKEN GLASS VIAL AND BACKFLOW OF THE PROGEL CONTENTS DURING USE. IT WAS FOUND THAT THE PROGEL CONTENT HAS SET UP WITHIN THE APPLICATORS SPRAY CHANNELS AND BACK FLOWED INTO THE APPLICATOR. BASED ON THE SAMPLE EVALUATION, AFTER THE PRODUCT WAS SET UP FOR USE, THE PROGEL CONTENTS LIKELY SET UP IN THE APPLICATOR CHANNELS RESULTING IN A TIP CLOG RESULTING IN THE NEED TO APPLY EXCESS FORCE RESULTING IN THE GLASS BREAK. UPDATED FIELDS: B4, D9, G3, G6, H2, H6, H10. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 0

    AS REPORTED, DURING A SEGMENTAL RESECTION FOR LUNG CANCER WHILE SPRAYING THE MIXTURE THE GLASS VIAL BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER LUNG SEALANT. THE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    AS REPORTED, DURING A SEGMENTAL RESECTION FOR LUNG CANCER WHILE SPRAYING THE MIXTURE THE GLASS VIAL BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER LUNG SEALANT. THE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373285 PROGEL PLATINUM PLEURAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC -2953195 NA IRHU0035 00801741010040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other