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

Catalog Number	PGPS002
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the progel cartridge had a shattered vial in it.The subject product was not available for evaluation; a photo was provided which showed a crack in one of the vials.The root cause of the cracked vial cannot be determined without the sample to evaluate, as such, no conclusion can be made.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 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." should additional information be provided, a supplemental mdr will be submitted.Not returned.
Event or Problem Description
As reported, during an unspecified procedure on (b)(6) 2020 it was noted that the progel kit had a shattered vial in it.Another progel kit was used to complete the procedure.The surgeon is an experienced user of the device.
Additional Manufacturer Narrative
As reported, the progel cartridge had a shattered vial in it.The subject product was not available for evaluation; a photo was provided which showed a crack in one of the vials.The root cause of the cracked vial cannot be determined without the sample to evaluate, as such, no conclusion can be made.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 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.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 unspecified procedure on (b)(6) 2020 it was noted that the progel kit had a shattered vial in it.Another progel kit was used to complete the procedure.The surgeon is an experienced user of the device.

• 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: 10934795
• Report Number: 1213643-2020-20062
• Device Sequence Number: 11452584
• Product Code: NBE
• UDI-Device Identifier: 00801741010026
• UDI-Public: (01)00801741010026
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• 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 Catalogue Number: PGPS002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 12/02/2020
• 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