MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-T&A PACK

Catalog Number	DYNJ89111
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "customer had a burn during procedure.".
Additional Manufacturer Narrative
The account reported finding cautery burn; no medical intervention, serious injury, or follow-up care has been reported.No sample or photo received for our investigation; the packs production record was reviewed and there were no line down situations, deviations, run-without, or non-conformance reports that might have had an impact on this issue.We were not able to confirm the reported issue as there were no samples or a detailed picture that depicted the issue that were received for this complaint investigation.It was reported that "it was determined at the facility that it was user error.They did not seat the blade firmly into the cautery pencil"; the cause text was unconfirmed defect, sample required to determine cause, and our 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-T&A PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884800
• Report Number: 1417592-2026-50073
• Device Sequence Number: 15893310
• Product Code: OGR
• UDI-Device Identifier: 10198459236365
• UDI-Public: 10198459236365
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 09/24/2026

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: DYNJ89111
• Device Lot Number: 25BBE048
• Was Device Available for Evaluation?: Yes
• 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: 04/09/2025
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown