MAUDE Adverse Event Report: NEOMEND INC -2953195 PROGEL PLATINUM 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	11/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported via maude event report (mw5105219): "the patient had a right thoracotomy/decortication surgery.The surgeon was using several of the progel syringes during the case (pleural air leak sealant).As he began to inject the progel into the chest cavity, one of the syringes broke inside the syringe chamber.He was unable to get any progel out of the tip of the syringe at this point.A few shards from the syringe landed on the sterile drape.The chest cavity was inspected and no syringe shards were found.The syringe was immediately removed from the field and sterility maintained.No harm came to the patient.Post-operative chest x-ray does not show foreign body in patient's chest.".
Additional Manufacturer Narrative
As reported, the progel glass vial broke inside the syringe chamber during application, the broken pieces were immediately removed from the field.There was no reported patient harm/injury.Contact information was not provided, therefore, we are unable to request additional information.Based on the information provided, and not having the sample to review, a root cause cannot be determined.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.(b)(4).
Additional Manufacturer Narrative
As reported, the progel glass vial broke inside the syringe chamber during application, the broken pieces were immediately removed from the field.There was no reported patient harm/injury.Contact information was not provided, therefore, we are unable to request additional information.Based on the information provided, and not having the sample to review, a root cause cannot be determined.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 september 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.
Event or Problem Description
The following was reported via maude event report (mw5105219): "the patient had a right thoracotomy/decortication surgery.The surgeon was using several of the progel syringes during the case (pleural air leak sealant).As he began to inject the progel into the chest cavity, one of the syringes broke inside the syringe chamber.He was unable to get any progel out of the tip of the syringe at this point.A few shards from the syringe landed on the sterile drape.The chest cavity was inspected and no syringe shards were found.The syringe was immediately removed from the field and sterility maintained.No harm came to the patient.Post-operative chest x-ray does not show foreign body in patient's chest.".

• Brand Name: PROGEL PLATINUM 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: 13125196
• Report Number: 1213643-2021-20496
• Device Sequence Number: 11220129
• Product Code: NBE
• UDI-Device Identifier: 00801741010026
• UDI-Public: (01)00801741010026(17)230101(10)IRFV0030
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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
• Initial Reporter Occupation: Nurse
• 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: 01/01/2023
• Device Catalogue Number: PGPS002
• Device Lot Number: IRFV0030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 12/31/2021
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2021
• 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