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

Catalog Number	DYNJ82657
Medical Device Problem Codes	Break (1069); Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that insulation on the suction cautery burning off during use, resulting in clear break of the product.
Additional Manufacturer Narrative
The account reported finding cautery burning off during use.A sample was received for the investigation, and medline received one used suction coagulator; the component received had a blue plastic body which does not match the suction coagulator in this kit¿s bom, and the insulation on the tip end does appear to have been burned slightly.Medline was unable to confirm the reported issue with the sample received as the received sample is not the suction coagulator that is in this kit's pack build; the cause was documented as unconfirmed defect, sample required to determine cause.The complaint has been provided to the vendor for further evaluation, supplier quality will monitor this issue for trending purposes, and no medical intervention, serious injury, or follow-up care has been 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.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 AND A PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50763055
• Report Number: 1417592-2026-39990
• Device Sequence Number: 9415104
• Product Code: OGR
• UDI-Device Identifier: 40195327199303
• UDI-Public: 40195327199303
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: DYNJ82657
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/22/2023
• 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: 08/18/2023
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (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