MAUDE Adverse Event Report: NEOMEND INC -2953195 PROGEL PLUERAL 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	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned for evaluation was the progel product in question and included the broken off piece of hsa glass cartridge.The hsa glass cartridge was found broken at the proximal end.The two hooks on the locking push rod are bent, indicating the damage occurred when trying to insert the push rod into the applicator housing.Based on the product condition, the damage to the push rod and hsa cartridge was inadvertently caused during user/ device interface due to forces applied while attempting to insert the locking push rod into the applicator housing.No manufacturing anomalies were found.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in november 2020.The instructions for use (ifu) supplied with this device lists, "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 on (b)(6) 2021, the progel was prepared and the vials inserted into the applicator.At this point a piece of glass was observed on the table, which prompted the tech to check the glass vials they had just inserted inside the applicator.It was noted that one of the vials was chipped.Another progel was used to complete the case and there was no reported patient injury.
Additional Manufacturer Narrative
Returned for evaluation was the progel product in question and included the broken off piece of hsa glass cartridge.The hsa glass cartridge was found broken at the proximal end.The two hooks on the locking push rod are bent, indicating the damage occurred when trying to insert the push rod into the applicator housing.Based on the product condition, the damage to the push rod and hsa cartridge was inadvertently caused during user/ device interface due to forces applied while attempting to insert the locking push rod into the applicator housing.No manufacturing anomalies were found.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of(b)(4) units released for distribution in (b)(6) 2020.The instructions for use (ifu) supplied with this device lists, "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 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 on (b)(6) 2021, the progel was prepared and the vials inserted into the applicator.At this point a piece of glass was observed on the table, which prompted the tech to check the glass vials they had just inserted inside the applicator.It was noted that one of the vials was chipped.Another progel was used to complete the case and there was no reported patient injury.

• Brand Name: PROGEL PLUERAL 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: 11396161
• Report Number: 1213643-2021-20044
• Device Sequence Number: 1165856
• Product Code: NBE
• UDI-Device Identifier: 00801741010026
• UDI-Public: (01)00801741010026(17)220526(10)IREW0024
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 05/26/2022
• Device Catalogue Number: PGPS002
• Device Lot Number: IREW0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2020
• 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