BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PLEURAL AIR LEAK SEALANT

    MDR report key: 10869121 · Received November 19, 2020

    Report

    Report Number
    1213643-2020-20047
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Date of Event
    October 28, 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
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE GLASS PEG AND HSA VIALS OF THE PROGEL CRACKED AFTER INITIAL PRESSURE WAS APPLIED DURING USE. THERE WAS NO REPORTED PATIENT INJURY/HARM. THE SUBJECT DEVICE WAS RETURNED FOR EVALUATION. IT WAS NOTED THAT BOTH PUSH RODS WERE REMOVED PRIOR TO SENDING BACK THE DEVICE SAMPLE FOR EVALUATION AND SOME PIECES OF GLASS FROM THE PRODUCT HAD BEEN DISCARDED. VISUAL EVALUATION CONFIRMED THE TWO GLASS CARTRIDGES WERE BROKEN AT THE PROXIMAL END. NO MANUFACTURING ANOMALIES WERE FOUND. IT IS POSSIBLE THE CARTRIDGE WAS INADVERTENTLY DAMAGED DURING SUBSEQUENT HANDLING OF THE PRODUCT IN PREPARATION FOR USE. BASED ON THE SAMPLE EVALUATION AND INVESTIGATION PERFORMED, THE REPORTED EVENT WAS CONFIRMED AND A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. REVIEW OF MANUFACTURING RECORDS INDICATE PRODUCT WAS MANUFACTURED TO SPECIFICATION. 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." ADDENDUM: 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, DURING A WEDGE RESECTION PROCEDURE ON (B)(6) 2020, THE OR TECH. PREPARED THE PROGEL PER INSTRUCTIONS FOR USE, USING PROPER TECHNIQUE. RESISTANCE WAS NOT FELT WHEN PURGING THE AIR PRIOR TO USE. THE PREPARED PROGEL APPLICATOR WAS HANDED TO THE SURGEON. AS THE SURGEON WAS ADVANCING THE PUSH ROD, IT WAS IMMEDIATELY NOTED THAT BOTH THE PEG (POLYETHYLENE GLYCOL) AND HSA (HUMAN SERUM ALBUMIN) VIALS WERE CRACKED. THE SURGEON DID NOT USE THE PROGEL PRODUCT AND A NEW KIT WAS PREPARED AND USED FROM A DIFFERENT LOT WITHOUT ANY ISSUE. AS REPORTED, THE OR STAFF AND SURGEON ARE EXPERIENCED IN USING PROGEL, ALL THE PRODUCTS ARE STORED IN THE REFRIGERATOR BETWEEN 36-46 DEGREE FAHRENHEIT AS RECOMMENDED. AS REPORTED, THE SURGEON DID NOT USE ANY EXCESSIVE FORCE WHEN APPLYING THE PROGEL. IT WAS ALSO REPORTED THAT SOME PIECES OF GLASS FROM THE PRODUCT HAD BEEN REMOVED AT THAT TIME AND DISCARDED. AS REPORTED, THERE WAS NO PATIENT HARM/INJURY AS A RESULT.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE GLASS PEG AND HSA VIALS OF THE PROGEL CRACKED AFTER INITIAL PRESSURE WAS APPLIED DURING USE. THERE WAS NO REPORTED PATIENT INJURY/HARM. THE SUBJECT DEVICE WAS RETURNED FOR EVALUATION. IT WAS NOTED THAT BOTH PUSH RODS WERE REMOVED PRIOR TO SENDING BACK THE DEVICE SAMPLE FOR EVALUATION AND SOME PIECES OF GLASS FROM THE PRODUCT HAD BEEN DISCARDED. VISUAL EVALUATION CONFIRMED THE TWO GLASS CARTRIDGES WERE BROKEN AT THE PROXIMAL END. NO MANUFACTURING ANOMALIES WERE FOUND. IT IS POSSIBLE THE CARTRIDGE WAS INADVERTENTLY DAMAGED DURING SUBSEQUENT HANDLING OF THE PRODUCT IN PREPARATION FOR USE. BASED ON THE SAMPLE EVALUATION AND INVESTIGATION PERFORMED, THE REPORTED EVENT WAS CONFIRMED AND A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. REVIEW OF MANUFACTURING RECORDS INDICATE PRODUCT WAS MANUFACTURED TO SPECIFICATION. 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."

    Description of Event or Problem · 1

    AS REPORTED, DURING A WEDGE RESECTION PROCEDURE ON (B)(6) 2020, THE OR TECH. PREPARED THE PROGEL PER INSTRUCTIONS FOR USE, USING PROPER TECHNIQUE. RESISTANCE WAS NOT FELT WHEN PURGING THE AIR PRIOR TO USE. THE PREPARED PROGEL APPLICATOR WAS HANDED TO THE SURGEON. AS THE SURGEON WAS ADVANCING THE PUSH ROD, IT WAS IMMEDIATELY NOTED THAT BOTH THE PEG (POLYETHYLENE GLYCOL) AND HSA (HUMAN SERUM ALBUMIN) VIALS WERE CRACKED. THE SURGEON DID NOT USE THE PROGEL PRODUCT AND A NEW KIT WAS PREPARED AND USED FROM A DIFFERENT LOT WITHOUT ANY ISSUE. AS REPORTED, THE OR STAFF AND SURGEON ARE EXPERIENCED IN USING PROGEL, ALL THE PRODUCTS ARE STORED IN THE REFRIGERATOR BETWEEN 36-46 DEGREE FAHRENHEIT AS RECOMMENDED. AS REPORTED, THE SURGEON DID NOT USE ANY EXCESSIVE FORCE WHEN APPLYING THE PROGEL. IT WAS ALSO REPORTED THAT SOME PIECES OF GLASS FROM THE PRODUCT HAD BEEN REMOVED AT THAT TIME AND DISCARDED. AS REPORTED, THERE WAS NO PATIENT HARM/INJURY AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336252 PROGEL PLEURAL AIR LEAK SEALANT SEALANT, POLYMERIZING NBE NEOMEND INC -2953195 NA IREV0018 00801741010026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other