MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - SPT MEDLINE; MINOR PACK-LF

Catalog Number	DYNJ0843099J
Medical Device Problem Codes	Fire (1245); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the needle tip of the bovie turned red and caught on fire "like a candle" while in use in the patient's groin.The surgeon requested water and put the fire out by dousing the bovie into the water pitcher.No patient injury was reported.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
It was reported that the needle tip of the bovie turned red and caught on fire "like a candle" while in use in the patient's groin.No patient injury was reported.

• Brand Name: MEDLINE
• Common Device Name: MINOR PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - SPT; 1170 s northpoint boulevard; waukegan IL 60085 6757
• Manufacturer Contact: nithla mathivanan ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25709249
• Report Number: 1423395-2026-00350
• Device Sequence Number: 5118573
• Product Code: LRO
• UDI-Device Identifier: 10198459119484
• UDI-Public: 10198459119484
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ0843099J
• Device Lot Number: 26DMC811
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 07/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2026
• 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
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Hispanic