BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PLEURAL AIR LEAK SEALANT

    MDR report key: 17424152 · Received July 31, 2023

    Report

    Report Number
    1213643-2023-00275
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Date of Event
    July 11, 2023
    Report Date
    September 4, 2024
    Manufacturer
    NEOMEND INC -2953195
    Product Code
    NBE
    UDI-DI
    00801741010026
    PMA / PMN Number
    P010047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, PROGEL CARTRIDGES WERE SHATTERED DURING APPLICATION. THE SUBJECT DEVICE HAS BEEN DISCARDED. BASED ON THE INFORMATION PROVIDED AND WITHOUT HAVING THE SAMPLE TO EVALUATE, NO CONCLUSION CAN BE MADE. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION, WITH NO INDICATION OF A MANUFACTURING RELATED CAUSE FOR THE EVENT REPORTED. TO DATE, (B)(4). 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 CARTRIDGES WERE SHATTERED DURING APPLICATION. THE SUBJECT DEVICE HAS BEEN DISCARDED. BASED ON THE INFORMATION PROVIDED AND WITHOUT HAVING THE SAMPLE TO EVALUATE, NO CONCLUSION CAN BE MADE. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION, WITH NO INDICATION OF A MANUFACTURING RELATED CAUSE FOR THE EVENT REPORTED. TO DATE, THIS IS THE ONLY COMPLAINT REPORTED FOR THIS MANUFACTURING LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION IN (B)(6) 2023. H11: THIS SUPPLEMENTAL MDR IS SUBMITTED TO CORRECT MEDICAL DEVICE MANUFACTURER AND UNIQUE IDENTIFIER (UDI). 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 ROBOTIC LUNG RESECTION PROCEDURE THE PROGEL WAS USED. IT WAS REPORTED THAT THE PROGEL WAS MIXED FOLLOWING THE MIXING PARAMETERS AND TIMELINE WITH PROPER IFU PROTOCOLS. IT WAS REPORTED THAT WHEN THE PHYSICIAN ASSISTANT WENT TO APPLY THE PROGEL, AND PRESSED ON THE LOCKING PUSH ROD, THE CARTRIDGES SHATTERED. IT WAS ALSO REPORTED THAT NO GLASS PIECES CAME OUT OF THE APPLICATOR HOUSING. ANOTHER PROGEL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    AS REPORTED, DURING A ROBOTIC LUNG RESECTION PROCEDURE THE PROGEL WAS USED. IT WAS REPORTED THAT THE PROGEL WAS MIXED FOLLOWING THE MIXING PARAMETERS AND TIMELINE WITH PROPER IFU PROTOCOLS. IT WAS REPORTED THAT WHEN THE PHYSICIAN ASSISTANT WENT TO APPLY THE PROGEL, AND PRESSED ON THE LOCKING PUSH ROD, THE CARTRIDGES SHATTERED. IT WAS ALSO REPORTED THAT NO GLASS PIECES CAME OUT OF THE APPLICATOR HOUSING. ANOTHER PROGEL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840014 PROGEL PLEURAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC -2953195 NA IRHQ0021 00801741010026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other