BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PLEURAL AIR LEAK SEALANT

    MDR report key: 10934795 · Received December 2, 2020

    Report

    Report Number
    1213643-2020-20062
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 11, 2020
    Report Date
    September 3, 2024
    Manufacturer
    NEOMEND INC -2953195
    Product Code
    NBE
    UDI-DI
    00801741010026
    PMA / PMN Number
    P010047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE PROGEL CARTRIDGE HAD A SHATTERED VIAL IN IT. THE SUBJECT PRODUCT WAS NOT AVAILABLE FOR EVALUATION; A PHOTO WAS PROVIDED WHICH SHOWED A CRACK IN ONE OF THE VIALS. THE ROOT CAUSE OF THE CRACKED VIAL CANNOT BE DETERMINED WITHOUT THE SAMPLE TO EVALUATE, AS SUCH, NO CONCLUSION CAN BE MADE. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THIS DEVICE LISTS, "DURING APPLICATOR ASSEMBLY, THE PROGEL¿ PUSH ROD IS DESIGNED TO LOCK IN TO THE APPLICATOR HOUSING. FORCED REMOVAL OF THE LOCKING PUSH ROD FROM THE APPLICATOR HOUSING MAY RESULT IN POTENTIAL DAMAGE TO THE APPLICATOR SYSTEM OR THE CHEMISTRY CARTRIDGES." H11: THIS SUPPLEMENTAL MDR IS SUBMITTED TO CORRECT MEDICAL DEVICE MANUFACTURER. 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 AN UNSPECIFIED PROCEDURE ON (B)(6) 2020 IT WAS NOTED THAT THE PROGEL KIT HAD A SHATTERED VIAL IN IT. ANOTHER PROGEL KIT WAS USED TO COMPLETE THE PROCEDURE. THE SURGEON IS AN EXPERIENCED USER OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE PROGEL CARTRIDGE HAD A SHATTERED VIAL IN IT. THE SUBJECT PRODUCT WAS NOT AVAILABLE FOR EVALUATION; A PHOTO WAS PROVIDED WHICH SHOWED A CRACK IN ONE OF THE VIALS. THE ROOT CAUSE OF THE CRACKED VIAL CANNOT BE DETERMINED WITHOUT THE SAMPLE TO EVALUATE, AS SUCH, NO CONCLUSION CAN BE MADE. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THIS DEVICE LISTS, "DURING APPLICATOR ASSEMBLY, THE PROGEL¿ PUSH ROD IS DESIGNED TO LOCK IN TO THE APPLICATOR HOUSING. FORCED REMOVAL OF THE LOCKING PUSH ROD FROM THE APPLICATOR HOUSING MAY RESULT IN POTENTIAL DAMAGE TO THE APPLICATOR SYSTEM OR THE CHEMISTRY CARTRIDGES." SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. NOT RETURNED.

    Description of Event or Problem · 1

    AS REPORTED, DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2020 IT WAS NOTED THAT THE PROGEL KIT HAD A SHATTERED VIAL IN IT. ANOTHER PROGEL KIT WAS USED TO COMPLETE THE PROCEDURE. THE SURGEON IS AN EXPERIENCED USER OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396945 PROGEL PLEURAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC -2953195 NA NI 00801741010026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other