MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-C-SECTION

Catalog Number	DYNJ900369I
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the entire version "i" of the kit was setup incorrectly with the cautery pen being put outside of the sterile portion of the kit, when traditionally it has always been in the sterile portion of the kit.
Additional Manufacturer Narrative
The account reported finding cautery put outside of sterile kit.A photo was received for the investigation, four photos were provided, finished good production records were reviewed, and the finished good pack build was reviewed; the production record had no line down situations, deviations, run-withouts, or non-conformance reports that might have had an impact on this issue.The reported problem was confirmed, as the cautery unit was observed placed outside of the pack in a bagged subassembly and the pack build review noted component 146574 - cautery penvac 10ft tbg holst was placed in the cds fold-tite outside of the cmpj.It was found that when the pack was moving to the "i" version the non-sterile cautery pen was moved from inside of the sterile cmpj to the non-sterile cds due to a pack setup error; the pack has now been revised to the "j" version and the component has been placed back inside of the sterile cmpj.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-C-SECTION
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: brianna montgomery ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50775220
• Report Number: 1417592-2026-40813
• Device Sequence Number: 15820661
• Product Code: OHM
• UDI-Device Identifier: 40195327276332
• UDI-Public: 40195327276332
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/10/2026

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: DYNJ900369I
• Device Lot Number: 22KBR847
• Was Device Available for Evaluation?: No
• 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: 01/25/2023
• Initial Report FDA Received Date: 09/15/2026
• 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