MAUDE Adverse Event Report: Medline Industries LP Medline; PLASTIC PACK

Catalog Number	DYNJT3195
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
"the smoke evac item catch fire which injured the surgeon".
Additional Manufacturer Narrative
It was reported that "the smoke evac item catch fire which injured the surgeon".No additional information is available at this time.There were no reports of death, serious injury, medical intervention, or follow-up care.It has been determined that the event did not involve a death or serious injury; however, it meets the definition of a reportable malfunction, as recurrence of the malfunction could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: Medline
• Common Device Name: PLASTIC PACK
• Manufacturer (Section D): Medline Industries LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50951511
• Report Number: 1423395-2026-00700
• Device Sequence Number: 16063886
• Product Code: FTN
• UDI-Device Identifier: 10198459312694
• UDI-Public: 10198459312694
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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
• Device Catalogue Number: DYNJT3195
• Device Lot Number: 26EMJ075
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 05/28/2026
• 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