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	01/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the progel glass vial broke during application.The surgeon may have been applying too much force when the vial broke inside the applicator.It is possible the cartridge was inadvertently damaged during use/device interface.However, based on the event as reported and not 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 608 units released for distribution in october, 2021.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 the end of a robotic converted to an open wedge resection procedure on (b)(6) 2022, the human serum albumin (hsa) vial of the bard/davol progel pleural air leak sealant shattered within the applicator during application of the sealant.As reported, the break occurred within the applicator and not on the patient.It was reported that the product was stored between 36°f-46°f and was used within 20 minutes of mixing the product.As reported, the cardiothoracic surgeon was not able to effectively use all of the sealant and the procedure was completed using another progel.As reported, the surgeon may have been applying too much force when the vial broke inside the applicator.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the progel glass vial broke during application.The surgeon may have been applying too much force when the vial broke inside the applicator.It is possible the cartridge was inadvertently damaged during use/device interface.However, based on the event as reported and not 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 608 units released for distribution in october, 2021.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 the end of a robotic converted to an open wedge resection procedure on (b)(6) 2022, the human serum albumin (hsa) vial of the bard/davol progel pleural air leak sealant shattered within the applicator during application of the sealant.As reported, the break occurred within the applicator and not on the patient.It was reported that the product was stored between 36°f-46°f and was used within 20 minutes of mixing the product.As reported, the cardiothoracic surgeon was not able to effectively use all of the sealant and the procedure was completed using another progel.As reported, the surgeon may have been applying too much force when the vial broke inside the applicator.There was no reported patient injury.
Event or Problem Description
As reported, during the end of a robotic converted to an open wedge resection procedure on (b)(6) 2022, the human serum albumin (hsa) vial of the bard/davol progel pleural air leak sealant shattered within the applicator during application of the sealant.As reported, the break occurred within the applicator and not on the patient.It was reported that the product was stored between 36°f-46°f and was used within 20 minutes of mixing the product.As reported, the cardiothoracic surgeon was not able to effectively use all of the sealant and the procedure was completed using another progel.As reported, the surgeon may have been applying too much force when the vial broke inside the applicator.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the progel glass vial broke during application.The surgeon may have been applying too much force when the vial broke inside the applicator.It is possible the cartridge was inadvertently damaged during use/device interface.However, based on the event as reported and not 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 october, 2021.Addendum: 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.

• 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: 13423811
• Report Number: 1213643-2022-00014
• Device Sequence Number: 5380067
• Product Code: NBE
• UDI-Device Identifier: 00801741010026
• UDI-Public: (01)00801741010026(17)230418(10)IRFX0002
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• 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: 04/18/2023
• Device Catalogue Number: PGPS002
• Device Lot Number: IRFX0002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2021
• 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