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

Catalog Number	PGPS002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the glass peg and hsa vials of the progel cracked after initial pressure was applied during use.There was no reported patient injury/harm.The subject device was returned for evaluation.It was noted that both push rods were removed prior to sending back the device sample for evaluation and some pieces of glass from the product had been discarded.Visual evaluation confirmed the two glass cartridges were broken at the proximal end.No manufacturing anomalies were found.It is possible the cartridge was inadvertently damaged during subsequent handling of the product in preparation for use.Based on the sample evaluation and investigation performed, the reported event was confirmed and a definitive root cause cannot be determined.Review of manufacturing records indicate product was manufactured to specification.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, during a wedge resection procedure on (b)(6) 2020, the or tech.Prepared the progel per instructions for use, using proper technique.Resistance was not felt when purging the air prior to use.The prepared progel applicator was handed to the surgeon.As the surgeon was advancing the push rod, it was immediately noted that both the peg (polyethylene glycol) and hsa (human serum albumin) vials were cracked.The surgeon did not use the progel product and a new kit was prepared and used from a different lot without any issue.As reported, the or staff and surgeon are experienced in using progel, all the products are stored in the refrigerator between 36-46 degree fahrenheit as recommended.As reported, the surgeon did not use any excessive force when applying the progel.It was also reported that some pieces of glass from the product had been removed at that time and discarded.As reported, there was no patient harm/injury as a result.
Event or Problem Description
As reported, during a wedge resection procedure on (b)(6) 2020, the or tech.Prepared the progel per instructions for use, using proper technique.Resistance was not felt when purging the air prior to use.The prepared progel applicator was handed to the surgeon.As the surgeon was advancing the push rod, it was immediately noted that both the peg (polyethylene glycol) and hsa (human serum albumin) vials were cracked.The surgeon did not use the progel product and a new kit was prepared and used from a different lot without any issue.As reported, the or staff and surgeon are experienced in using progel, all the products are stored in the refrigerator between 36-46 degree fahrenheit as recommended.As reported, the surgeon did not use any excessive force when applying the progel.It was also reported that some pieces of glass from the product had been removed at that time and discarded.As reported, there was no patient harm/injury as a result.
Additional Manufacturer Narrative
As reported, the glass peg and hsa vials of the progel cracked after initial pressure was applied during use.There was no reported patient injury/harm.The subject device was returned for evaluation.It was noted that both push rods were removed prior to sending back the device sample for evaluation and some pieces of glass from the product had been discarded.Visual evaluation confirmed the two glass cartridges were broken at the proximal end.No manufacturing anomalies were found.It is possible the cartridge was inadvertently damaged during subsequent handling of the product in preparation for use.Based on the sample evaluation and investigation performed, the reported event was confirmed and a definitive root cause cannot be determined.Review of manufacturing records indicate product was manufactured to specification.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." 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 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: 10869121
• Report Number: 1213643-2020-20047
• Device Sequence Number: 19491964
• Product Code: NBE
• UDI-Device Identifier: 00801741010026
• UDI-Public: (01)00801741010026(17)220404(10)IREV0018
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Physician
• 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: 04/04/2022
• Device Catalogue Number: PGPS002
• Device Lot Number: IREV0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2020
• 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