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	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, while assembling the bard/davol progel pleural air leak sealant during a procedure on (b)(6) 2022, the liquid vial broke.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the bard/davol progel glass vial broke during assembly; there was no reported patient injury.Additional information was requested, but not provided.Based on the limited information provided, and not having the sample to review, a root cause cannot be determined.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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.".
Event or Problem Description
As reported, while assembling the bard/davol progel pleural air leak sealant during a procedure on (b)(6) 2022, the liquid vial broke.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the bard/davol progel glass vial broke during assembly; there was no reported patient injury.Additional information was requested, but not provided.Based on the limited information provided, and not having the sample to review, a root cause cannot be determined.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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." h11: this supplemental mdr is submitted to correct medical device manufacturer.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 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: 14401416
• Report Number: 1213643-2022-00228
• Device Sequence Number: 20215725
• Product Code: NBE
• UDI-Device Identifier: 00801741010026
• UDI-Public: (01)00801741010026
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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 Catalogue Number: PGPS002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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