MAUDE Adverse Event Report: NEOMEND INC -2953195 PROGEL PLATINUM 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	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, progel vial broke after user attempted to remove push rod.Review of the photo finds that one of the glass cartridges is broken at the proximal end where the push rod is inserted.The push rod is not in straight alignment with the cartridges and applicator housing.Based on the photos and information provided the broken glass is due to attempting to remove the push rod after use.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 162 units released for distribution in october, 2023.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." 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
It was reported that after a video-assisted thoracoscopic surgery (vats) the user attempted to remove the push rod from the applicator after attempted use.This resulted a glass vial break and push rod becoming twisted.The product was used within 20 minutes of mixing peg and sterile water and the vial did not break when attempting to use the device.Another progel was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that after a video-assisted thoracoscopic surgery (vats) the user attempted to remove the push rod from the applicator after attempted use.This resulted a glass vial break and push rod becoming twisted.The product was used within 20 minutes of mixing peg and sterile water and the vial did not break when attempting to use the device.Another progel was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, progel vial broke after user attempted to remove push rod.Review of the photo finds that one of the glass cartridges is broken at the proximal end where the push rod is inserted.The push rod is not in straight alignment with the cartridges and applicator housing.Based on the photos and information provided the broken glass is due to attempting to remove the push rod after use.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 october, 2023.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." addendum: h11: this supplemental mdr is submitted to correct medical device manufacturer and 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.

• Brand Name: PROGEL PLATINUM 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: 18364361
• Report Number: 1213643-2023-00512
• Device Sequence Number: 20836796
• Product Code: NBE
• UDI-Device Identifier: 00801741010026
• UDI-Public: (01)00801741010026(17)250607(10)IRHW0022
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 06/07/2025
• Device Catalogue Number: PGPS002
• Device Lot Number: IRHW0022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2023
• 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