MAUDE Adverse Event Report: NEOMEND INC. PROGEL PLEURAL AIR LEAK SEALANT SYRINGE 4 ML PROGEL; SEALANT, POLYMERIZING

Model Number	M-00331
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 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.Fda safety report id # (b)(4).

• Brand Name: PROGEL PLEURAL AIR LEAK SEALANT SYRINGE 4 ML PROGEL
• Common Device Name: SEALANT, POLYMERIZING
• Manufacturer (Section D): NEOMEND INC.
• MDR Report Key: 12786815
• Report Number: MW5105219
• Device Sequence Number: 12156469
• Product Code: NBE
• UDI-Device Identifier: 00801741010026
• UDI-Public: (01)00801741010026(17)230101(10)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/05/2021

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 Model Number: M-00331
• Device Catalogue Number: REF: PGPS002
• Device Lot Number: IRFV0030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 121 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White