BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PLATINUM PLEURAL AIR LEAK SEALANT

    MDR report key: 20055524 · Received August 23, 2024

    Report

    Report Number
    1213643-2024-00419
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 24, 2024
    Report Date
    August 30, 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, PROGEL PLATINUM CARTRIDGE BROKE DURING PREPARATION. REVIEW OF THE PHOTOS PROVIDED SHOWS A PROGEL PLATINUM APPLICATOR THAT HAS BEEN SET UP FOR USE AND ONE OF THE GLASS CARTRIDGES HAS BROKEN. THE SPRAY TIP IS NOT LOCKED INTO PLACE TO THE APPLICATION HOUSING LIKELY RESULTING IN SPRAY CHANNELS BECOMING CLOGGED WITH THE PROGEL MATERIAL. BASED ON THE PHOTOS THE GLASS LIKELY BROKEN DUE TO EXCESS FORCES APPLIED TO DEPLOY THE MATERIAL CAUSING THE GLASS BREAK. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION, WITH NO INDICATION OF A MANUFACTURING RELATED CAUSE FOR THE EVENT REPORTED. THE IFU FOR THE PROGEL PLATINUM ADEQUATELY PRESCRIBES THE PROPER INSPECTION AND PREPARATION METHOD TO PREVENT DAMAGE TO THE PRODUCT. PROGEL PLATINUM IS NOT APPROVED FOR USE IN THE USA. THIS REPORT IS A SIMILAR DEVICE REPORT FOR PROGEL, WHICH IS APPROVE/MARKETED IN THE USA. ADDENDUM: THIS IS AN ADDENDUM TO THE INITIAL MDR SUBMITTED. 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. AS THE DEVICE WAS RECEIVED WITH A BROKEN VIAL AFTER SETTING UP AND USE SHOWS THE ROOT CAUSE IS THAT THE SPRAY TIP WAS NOT FULLY ATTACHED TO THE APPLICATOR. THIS RESULTED IN A TIP CLOG WHICH CAUSED THE BACKFLOW OF THE CONTENTS INTO THE HOUSING. FORCES APPLIED WITH A CLOGGED TIP RESULTED IN THE GLASS BREAK FOUND. UPDATED FIELDS: B4, D9, G3, G6, H2, H3, 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.

    Additional Manufacturer Narrative · 0

    AS REPORTED, PROGEL PLATINUM CARTRIDGE BROKE DURING PREPARATION. REVIEW OF THE PHOTOS PROVIDED SHOWS A PROGEL PLATINUM APPLICATOR THAT HAS BEEN SET UP FOR USE AND ONE OF THE GLASS CARTRIDGES HAS BROKEN. THE SPRAY TIP IS NOT LOCKED INTO PLACE TO THE APPLICATION HOUSING LIKELY RESULTING IN SPRAY CHANNELS BECOMING CLOGGED WITH THE PROGEL MATERIAL. BASED ON THE PHOTOS THE GLASS LIKELY BROKEN DUE TO EXCESS FORCES APPLIED TO DEPLOY THE MATERIAL CAUSING THE GLASS BREAK. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION, WITH NO INDICATION OF A MANUFACTURING RELATED CAUSE FOR THE EVENT REPORTED. THE IFU FOR THE PROGEL PLATINUM ADEQUATELY PRESCRIBES THE PROPER INSPECTION AND PREPARATION METHOD TO PREVENT DAMAGE TO THE PRODUCT. PROGEL PLATINUM IS NOT APPROVED FOR USE IN THE USA. THIS REPORT IS A SIMILAR DEVICE REPORT FOR PROGEL, WHICH IS APPROVE/MARKETED IN THE USA. 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, THE PROGEL PLATINUM SURGICAL SEALANT WAS USED DURING A WEDGE RESECTION FOR LUNG CANCER AND THE CARTRIDGE BROKE WHEN ATTEMPTING TO SPRAY THE PRODUCT. ANOTHER LUNG SEALANT WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    AS REPORTED, THE PROGEL PLATINUM SURGICAL SEALANT WAS USED DURING A WEDGE RESECTION FOR LUNG CANCER AND THE CARTRIDGE BROKE WHEN ATTEMPTING TO SPRAY THE PRODUCT. ANOTHER LUNG SEALANT WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618599 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