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	06/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the progel glass vial broke during preparation.The subject device was not returned for evaluation.Based on the information provided and without having the sample to evaluate, no conclusion can be made.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." 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 600 units released for distribution in february, 2022.Not returned.
Event or Problem Description
As reported during an unknown procedure on (b)(6) 2022, the bard/davol progel glass vial broke during preparation.It was reported that the broken glass vial and applicator was removed and another progel was used to complete the case.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the progel glass vial broke during preparation.The subject device was not returned for evaluation.Based on the information provided and without having the sample to evaluate, no conclusion can be made.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." 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 (b)(6) 2022.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 unknown procedure on (b)(6) 2022, the bard/davol progel glass vial broke during preparation.It was reported that the broken glass vial and applicator was removed and another progel was used to complete the case.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: 15076223
• Report Number: 1213643-2022-00524
• Device Sequence Number: 17348914
• Product Code: NBE
• UDI-Device Identifier: 00801741010026
• UDI-Public: (01)00801741010026(17)230801(10)IRGN0024
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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,Health Professional,User Facility
• 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: 08/01/2023
• Device Catalogue Number: PGPS002
• Device Lot Number: IRGN0024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2022
• 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