MAUDE Adverse Event Report: NEOMEND INC -2953195 PROGEL PLEURAL AIR LEAK SEALANT; SEALANT, POLYMERIZING

Catalog Number	PGPS002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the progel glass vial cracked during application.Returned for evaluation was the progel product in question.As received, the progel appears to have been unused.Visual evaluation confirms one of the glass cartridges is broken, near the spray tip and the broken off piece was noticed to have fallen between the glass cartridges inside the applicator housing.The applicator housing is in good condition and no manufacturing anomalies were found.It is possible the cartridge was inadvertently damaged during use/device interface; however, a definitive cause of the broken glass cartridge at time of use cannot be determined.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 released for distribution in november, 2021.
Event or Problem Description
As reported, during an open thoracotomy wedge resection procedure on (b)(6) 2022, while using the bard/davol progel pleural air leak sealant (pals), the tip became clogged and was exchanged.As reported, when the surgeon attempted to spray the surgical site, the human serum albumin (hsa) glass vial shattered within the applicator.The broken glass was contained within the applicator.The surgeon was able to complete the case with the product that was used.As reported, the product was refrigerated between 36-46°f as recommended, was assembled properly and was used within 20 minutes of mixing the product.There was no reported patient harm/injury as a result.
Additional Manufacturer Narrative
As reported, the progel glass vial cracked during application.Returned for evaluation was the progel product in question.As received, the progel appears to have been unused.Visual evaluation confirms one of the glass cartridges is broken, near the spray tip and the broken off piece was noticed to have fallen between the glass cartridges inside the applicator housing.The applicator housing is in good condition and no manufacturing anomalies were found.It is possible the cartridge was inadvertently damaged during use/device interface; however, a definitive cause of the broken glass cartridge at time of use cannot be determined.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 576 units released for distribution in november, 2021 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.
Event or Problem Description
As reported, during an open thoracotomy wedge resection procedure on (b)(6) 2022, while using the bard/davol progel pleural air leak sealant (pals), the tip became clogged and was exchanged.As reported, when the surgeon attempted to spray the surgical site, the human serum albumin (hsa) glass vial shattered within the applicator.The broken glass was contained within the applicator.The surgeon was able to complete the case with the product that was used.As reported, the product was refrigerated between 36-46°f as recommended, was assembled properly and was used within 20 minutes of mixing the product.There was no reported patient harm/injury as a result.

• Brand Name: PROGEL PLEURAL AIR LEAK SEALANT
• Common Device Name: SEALANT, POLYMERIZING
• Manufacturer (Section D): NEOMEND INC -2953195; 60 technology drive; irvine CA 92618
• Manufacturer (Section G): NEOMEND INC -2953195; 60 technology drive; irvine CA 92618
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 13590203
• Report Number: 1213643-2022-00022
• Device Sequence Number: 17657964
• Product Code: NBE
• UDI-Device Identifier: 00801741010026
• UDI-Public: (01)00801741010026(17)230522(10)IRFX0028
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P010047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2023
• Device Catalogue Number: PGPS002
• Device Lot Number: IRFX0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown