BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PLEURAL AIR LEAK SEALANT

    MDR report key: 23817281 · Received December 16, 2025

    Report

    Report Number
    1213643-2025-01223
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    December 2, 2025
    Report Date
    December 5, 2025
    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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE GLASS VIAL OF PROGEL PLEURAL AIR LEAK SEALANT SHATTERED WHEN THE PLUNGER WAS DEPRESSED TO LOCK THE VIALS IN PLACE. EVALUATION OF THE SAMPLE CONFIRMS A BROKEN GLASS VIAL AND BACKFLOW OF THE PROGEL CONTENTS DURING USE AND THE SAMPLE WAS INADVERTENTLY DAMAGED DURING SET UP. THE USER REPORTED HAVING TO REMOVE THE VIALS AND REINSERT THEM USING THE PUSH ROD TO LOCK THE VIALS IN PLACE. FORCES APPLIED WHILE USING THE PUSH RID TO PUSH THE VIALS INTO THE HOUSING LIKELY RESULTED IN THE BROKEN GLASS IN SETUP. NO MANUFACTURING ANOMALIES WERE FOUND. BASED ON THE SAMPLE EVALUATION AND INVESTIGATION PERFORMED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE IFU FOR THE PROGEL PLEURAL AIR LEAK SEALANT ADEQUATELY PRESCRIBES THE PROPER INSPECTION AND PREPARATION METHOD TO PREVENT DAMAGE TO THE PRODUCT. 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 REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. 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 LEFT VIDEO ASSISTED THORACIC SURGERY, THE GLASS VIAL OF PROGEL PLEURAL AIR LEAK SEALANT SHATTERED WHEN THE PLUNGER WAS DEPRESSED TO LOCK THE VIALS IN PLACE. NO EXCESSIVE FORCE WAS APPLIED. THE PROGEL PRODUCT WAS STORED AT 2 TO 8 DEGREE CELSIUS AND WAS PREPARED BY THE SCRUB NURSE, WHO IS FAMILIAR WITH ITS USE. ANOTHER PROGEL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT OR USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2281768 PROGEL PLEURAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC -2953195 NA IRKU0037 00801741010026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other