MAUDE Adverse Event Report: INTEGRA - PRINCETON MICROMYST APPLICATOR BOX OF 5; SEALANT APPLICATORS

Catalog Number	205000DS
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that upon application of micromyst (205000ds), the first applicator was not administering a fine spray.It sprayed for a short while, then came out blobby and then stopped spraying altogether.After doing some trouble shooting, nothing worked, so they opened the second applicator, and it did the same thing.The 3rd applicator worked fine.The surgeon did comment that the first 2 times it felt different as though he had to use more force to apply the duraseal.The surgeon used the product on patient, but there was no patient injury or death.The incident caused increased surgery time of 30 minutes.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.The micromyst applicator (205000ds) was not returned for evaluation.However, lot number information was provided and the dhr review confirmed the finished good for the work order was processed within qualified parameters and passed the required inspection checks, and there were no non-conformances related to this lot.Due to no product return, the root cause is undetermined and was unable to be confirmed in the complaint evaluation.Per the dfmea, potential causes of failure include: issues with solution mixing and coverage.No capa has been issued/opened for the reported failure, and no capa is recommended at this time, as this complaint issue does not represent an adverse trend, unacceptable individual risk, or significant non-conformance to regulatory requirements.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: MICROMYST APPLICATOR BOX OF 5
• Common Device Name: SEALANT APPLICATORS
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ 08540
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ 08540
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21323210
• Report Number: 3003418325-2025-00006
• Device Sequence Number: 18263874
• Product Code: FMF
• UDI-Device Identifier: 10381780000112
• UDI-Public: 10381780000112
• Combination Product (Y/N): N
• PMA/510(K) Number: K082454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: 205000DS
• Device Lot Number: 2023070073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 04/24/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown