MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-VASCULAR MINOR PACK

Catalog Number	DYNJ62097C
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "neptune bovie pencil are giving an error message on the machine.When pulled a single sterile component, did not have the issue.Switch seemed to be stuck on ¿cut¿".
Additional Manufacturer Narrative
The account reported finding defective bovie pencil, and the end user reported that the component was giving an error message on the machine and the switch appeared to be stick on the cut function.Medline received one bovie pencil as a sample for investigation, observed no visual or physical damage or defects with the received component, reviewed finished good production records, and reviewed the finished good pack build.With one returned sample, the vendor was able to confirm the failure of the component; however, they were unable to determine the root cause of the problem reported as it has been manufactured compliantly, and no manufacturing non-conformance was identified in their process.Medline concluded that the complaint has been provided to the vendor for further evaluation and the supplier quality team will monitor this issue for trending purposes.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.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-VASCULAR MINOR PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50714510
• Report Number: 1417592-2026-35715
• Device Sequence Number: 16101720
• Product Code: OEZ
• UDI-Device Identifier: 40195327189830
• UDI-Public: 40195327189830
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/05/2026

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: DYNJ62097C
• Device Lot Number: 23ABN220
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/10/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown