BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PLEURAL AIR LEAK SEALANT

    MDR report key: 14401416 · Received May 13, 2022

    Report

    Report Number
    1213643-2022-00228
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    April 14, 2022
    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
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE BARD/DAVOL PROGEL GLASS VIAL BROKE DURING ASSEMBLY; THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED, AND NOT HAVING THE SAMPLE TO REVIEW, A ROOT CAUSE CANNOT BE DETERMINED. 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 STATES "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."

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE BARD/DAVOL PROGEL GLASS VIAL BROKE DURING ASSEMBLY; THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED, AND NOT HAVING THE SAMPLE TO REVIEW, A ROOT CAUSE CANNOT BE DETERMINED. 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 STATES "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, WHILE ASSEMBLING THE BARD/DAVOL PROGEL PLEURAL AIR LEAK SEALANT DURING A PROCEDURE ON (B)(6) 2022, THE LIQUID VIAL BROKE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    AS REPORTED, WHILE ASSEMBLING THE BARD/DAVOL PROGEL PLEURAL AIR LEAK SEALANT DURING A PROCEDURE ON (B)(6) 2022, THE LIQUID VIAL BROKE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040271 PROGEL PLEURAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC -2953195 NA NI 00801741010026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other