MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP OPTICLOSE; OPTICLOSE RAPID ADHESIVE, 0.8ML

Catalog Number	MSC091050
Medical Device Problem Codes	Material Fragmentation (1261); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, a physician attempted to apply opticlose to a wound using the new skin glue applicator in a normal manner.Upon breaking the ampule using the wings, the top dislodged and the internal glass ampule shattered, resulting in glass shards contacting the patient's skin and incision site.The site was cleaned and re soaked with irrisept, and steri strips were used to complete the case.No additional information is available at this time.
Additional Manufacturer Narrative
According to the facility, a physician attempted to apply opticlose to a wound using the new skin glue applicator in a normal manner.Upon breaking the ampule using the wings, the top dislodged and the internal glass ampule shattered, resulting in glass shards contacting the patient's skin and incision site.The site was cleaned and re soaked with irrisept, and steri strips were used to complete the case.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: OPTICLOSE
• Common Device Name: OPTICLOSE RAPID ADHESIVE, 0.8ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24776752
• Report Number: 1417592-2026-00361
• Device Sequence Number: 21313545
• Product Code: MPN
• UDI-Device Identifier: 10888277728608
• UDI-Public: 10888277728608
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K132243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MSC091050
• Device Lot Number: P00246008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown