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	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a lobectomy procedure the progel sealant was prepped as directed and used within 20 minutes, however, it hardened up before sprayed and would not release the product.As reported, the procedure was completed using another progel.Sample evaluation found broken glass vial.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, progel failed to dispense sealant.Evaluation of the sample confirms a broken glass vial and backflow of the progel contents during use.Some of the progel content had been expelled from the device in use.Based on the sample condition it is possible the vial was inadvertently damaged during subsequent handling and or forces applied to the device during setup / use of the product.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 nov, 2022.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.Sample evaluated.
Additional Manufacturer Narrative
As reported, progel failed to dispense sealant.Evaluation of the sample confirms a broken glass vial and backflow of the progel contents during use.Some of the progel content had been expelled from the device in use.Based on the sample condition it is possible the vial was inadvertently damaged during subsequent handling and or forces applied to the device during setup / use of the product.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 nov, 2022.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document sample evaluation results.Further evaluation of the sample finds that the product was not properly purged of air bubbles prior to use.This likely resulted in the need to apply extra and uneven force to the push rod to dispense the product.This uneven force was seen in the broken cartridge and uneven advancement of the cartridge plungers.Based on the sample evaluation and investigation performed, the most probable root cause is improper setup and forces applied to the device during setup / use of the product.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 a lobectomy procedure the progel sealant was prepped as directed and used within 20 minutes, however, it hardened up before sprayed and would not release the product.As reported, the procedure was completed using another progel.Sample evaluation found broken glass vial.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, progel failed to dispense sealant.Evaluation of the sample confirms a broken glass vial and backflow of the progel contents during use.Some of the progel content had been expelled from the device in use.Based on the sample condition it is possible the vial was inadvertently damaged during subsequent handling and or forces applied to the device during setup / use of the product.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 nov, 2022.Addendum #1: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document sample evaluation results.Further evaluation of the sample finds that the product was not properly purged of air bubbles prior to use.This likely resulted in the need to apply extra and uneven force to the push rod to dispense the product.This uneven force was seen in the broken cartridge and uneven advancement of the cartridge plungers.Based on the sample evaluation and investigation performed, the most probable root cause is improper setup and forces applied to the device during setup / use of the product.Addendum #2: h11: this supplemental mdr is submitted to correct medical device manufacturer and unique identifier (udi).Corrected fields: d3 (medical device manufacturer), d4 (unique identifier (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 a lobectomy procedure the progel sealant was prepped as directed and used within 20 minutes, however, it hardened up before sprayed and would not release the product.As reported, the procedure was completed using another progel.Sample evaluation found broken glass vial.There was no reported patient injury.

• 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: 17172762
• Report Number: 1213643-2023-00239
• Device Sequence Number: 20244450
• Product Code: NBE
• UDI-Device Identifier: 00801741010026
• UDI-Public: (01)00801741010026(17)240612(10)IRGX0018
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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,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: 06/12/2024
• Device Catalogue Number: PGPS002
• Device Lot Number: IRGX0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 06/22/2023; 09/03/2024
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 06/28/2023; 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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