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	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, progel cartridges were shattered during application.The subject device has been discarded.Based on the information provided and without having the sample to evaluate, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, (b)(4).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 robotic lung resection procedure the progel was used.It was reported that the progel was mixed following the mixing parameters and timeline with proper ifu protocols.It was reported that when the physician assistant went to apply the progel, and pressed on the locking push rod, the cartridges shattered.It was also reported that no glass pieces came out of the applicator housing.Another progel was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, progel cartridges were shattered during application.The subject device has been discarded.Based on the information provided and without having the sample to evaluate, no conclusion can be made.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 complaint reported for this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2023.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.
Event or Problem Description
As reported, during a robotic lung resection procedure the progel was used.It was reported that the progel was mixed following the mixing parameters and timeline with proper ifu protocols.It was reported that when the physician assistant went to apply the progel, and pressed on the locking push rod, the cartridges shattered.It was also reported that no glass pieces came out of the applicator housing.Another progel was used to complete the procedure.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: 17424152
• Report Number: 1213643-2023-00275
• Device Sequence Number: 12676948
• Product Code: NBE
• UDI-Device Identifier: 00801741010026
• UDI-Public: (01)00801741010026(17)241016(10)IRHQ0021
• Combination Product (Y/N): Y
• 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: 10/16/2024
• Device Catalogue Number: PGPS002
• Device Lot Number: IRHQ0021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2023
• 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