BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PLATINUM PLEURAL AIR LEAK SEALANT

    MDR report key: 10593527 · Received September 28, 2020

    Report

    Report Number
    1213643-2020-20004
    Event Type
    Malfunction
    Date Received
    September 28, 2020
    Date of Event
    September 1, 2020
    Report Date
    September 4, 2024
    Manufacturer
    NEOMEND INC -2953195
    Product Code
    NBE
    UDI-DI
    00801741010040
    PMA / PMN Number
    P010047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND THEREFORE UNAVAILABLE FOR REVIEW. BASED ON THE EVENT AS REPORTED AND NOT HAVING THE SAMPLE TO EVALUATE, NO CONCLUSION CAN BE MADE. HOWEVER, AS REPORTED THE BROKEN PEG GLASS CARTRIDGE WAS NOT AN OUT OF BOX EVENT. IT IS POSSIBLE THE CARTRIDGE WAS INADVERTENTLY DAMAGED DURING SUBSEQUENT HANDLING OF THE PRODUCT IN PREPARATION FOR USE. THE IFU FOR THE PROGEL PLATINUM ADEQUATELY PRESCRIBES THE PROPER INSPECTION AND PREPARATION METHOD TO PREVENT DAMAGE TO THE PRODUCT. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FROM THIS MANUFACTURING LOT OF(B)(4) UNITS RELEASED FOR DISTRIBUTION IN (B)(6) 2020. THE SUBJECT PRODUCT IS NOT MARKETED FOR US SALES. A SIMILAR PRODUCT IS MARKETED IN THE US. H11: THIS SUPPLEMENTAL MDR IS SUBMITTED TO CORRECT MEDICAL DEVICE MANUFACTURER AND 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, ON (B)(6) 2020, PRIOR TO USE IN THE PROGEL PLATINUM SEALANT CARTRIDGES (GLASS VIAL) BROKE WHEN IT WAS INSERTED IN THE SEALANT APPLICATOR DURING DEVICE PREPARATION FOR USE. THERE WAS NO USER INJURY REPORTED AS A RESULT OF THE PROBLEM EXPERIENCED. ANOTHER PROGEL PLATINUM DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THE PROBLEM EXPERIENCED IN PREPARATION FOR USE DID NOT IMPACT THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND THEREFORE UNAVAILABLE FOR REVIEW. BASED ON THE EVENT AS REPORTED AND NOT HAVING THE SAMPLE TO EVALUATE, NO CONCLUSION CAN BE MADE. HOWEVER, AS REPORTED THE BROKEN PEG GLASS CARTRIDGE WAS NOT AN OUT OF BOX EVENT. IT IS POSSIBLE THE CARTRIDGE WAS INADVERTENTLY DAMAGED DURING SUBSEQUENT HANDLING OF THE PRODUCT IN PREPARATION FOR USE. THE IFU FOR THE PROGEL PLATINUM ADEQUATELY PRESCRIBES THE PROPER INSPECTION AND PREPARATION METHOD TO PREVENT DAMAGE TO THE PRODUCT. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FROM THIS MANUFACTURING LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION IN (B)(4) 2020. THE SUBJECT PRODUCT IS NOT MARKETED FOR US SALES. A SIMILAR PRODUCT IS MARKETED IN THE US. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED, ON (B)(6) 2020, PRIOR TO USE IN THE PROGEL PLATINUM SEALANT CARTRIDGES (GLASS VIAL) BROKE WHEN IT WAS INSERTED IN THE SEALANT APPLICATOR DURING DEVICE PREPARATION FOR USE. THERE WAS NO USER INJURY REPORTED AS A RESULT OF THE PROBLEM EXPERIENCED. ANOTHER PROGEL PLATINUM DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THE PROBLEM EXPERIENCED IN PREPARATION FOR USE DID NOT IMPACT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057989 PROGEL PLATINUM PLEURAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC -2953195 NA IREP0021 00801741010040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other