MAUDE Adverse Event Report: NEOMEND INC -2953195 PROGEL PLUERAL AIR LEAK SEALANT; SEALANT, POLYMERIZING

Catalog Number	PGPS002
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample evaluation performed confirms the peg glass cartridge to be broken at the proximal end at the locking push rod.One of the hooks on the locking push rod is bent and remained inside of the broken piece of the peg cartridge holding the broken piece in place on the push rod.Based on the product condition, the damage to the push rod and peg cartridge was inadvertently caused during user/ device interface and occurred due to forces applied and improper set up.While inserting the locking push rod into the applicator housing one of the hooks on the locking push rod was inserted into the peg cartridge resulting the damage found.Per the instructions-for-use, without the spray tip attached, point the applicator housing upward and load each cartridge into the dual-barrel applicator housing.Cartridges can be loaded into the delivery system in any order.Gently press the cartridges to seat them into place.Note: when properly loaded the chemistry cartridges should sit flush with the end of the applicator housing.Without the spray tip attached, point the applicator housing upward to allow any air in the chemistry to rise to the top of the cartridges.Insert the locking push rod into the openings in the rear of the cartridges until it snaps into place.Note: 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.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in february, 2019.
Event or Problem Description
It was reported that, during an unspecified procedure, the progel pleural air leak sealant plunger was bent and the barrel broke and the product was not used.The case was completed with a new progel kit.No patient safety was compromised.As reported, per the customer contact, the progel was not assembled, the plunger was fully aligned; the top of the barrel may be broken and the glass vials were not broken.
Event or Problem Description
It was reported that, during an unspecified procedure, the progel pleural air leak sealant plunger was bent and the barrel broke and the product was not used.The case was completed with a new progel kit.No patient safety was compromised.As reported, per the customer contact, the progel was not assembled, the plunger was fully aligned; the top of the barrel may be broken and the glass vials were not broken.
Additional Manufacturer Narrative
The sample evaluation performed confirms the peg glass cartridge to be broken at the proximal end at the locking push rod.One of the hooks on the locking push rod is bent and remained inside of the broken piece of the peg cartridge holding the broken piece in place on the push rod.Based on the product condition, the damage to the push rod and peg cartridge was inadvertently caused during user/ device interface and occurred due to forces applied and improper set up.While inserting the locking push rod into the applicator housing one of the hooks on the locking push rod was inserted into the peg cartridge resulting the damage found.Per the instructions-for-use, without the spray tip attached, point the applicator housing upward and load each cartridge into the dual-barrel applicator housing.Cartridges can be loaded into the delivery system in any order.Gently press the cartridges to seat them into place.Note: when properly loaded the chemistry cartridges should sit flush with the end of the applicator housing.Without the spray tip attached, point the applicator housing upward to allow any air in the chemistry to rise to the top of the cartridges.Insert the locking push rod into the openings in the rear of the cartridges until it snaps into place.Note: 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.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in february, 2019.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 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: 11162633
• Report Number: 1213643-2021-20002
• Device Sequence Number: 677288
• Product Code: NBE
• UDI-Device Identifier: 00801741010026
• UDI-Public: (01)00801741010026(17)201220(10)IRDN0008
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 12/20/2020
• Device Catalogue Number: PGPS002
• Device Lot Number: IRDN0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2019
• 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