MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-GENERAL MAJOR 668230-V

Catalog Number	DYNJ58504F
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The account reported finding light handle cover breaks during removal.A photo and a sample were received for the investigation; the sample evaluation found two light handle covers, one with the inner ring completely broken off, and finished good production records, finished good pack build, trending, component trending, the bill of materials (bom), and production records were reviewed.Based on the review of the reported complaint, the provided sample and photo, and the investigation, medline confirmed the reported issue.Further investigation revealed that the root cause is attributed to a vendor product issue related to the component manufacturing process; the complaint was provided to the component manufacturing facility for further evaluation, supplier quality will monitor this issue for trending purposes, and the incident was found to be acceptable.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.
Event or Problem Description
It was reported that "inner ring of light handle cover came off as nurse pull handle off light.".

• Brand Name: MEDLINE
• Common Device Name: DBD-GENERAL MAJOR 668230-V
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50221261
• Report Number: 1417592-2026-15815
• Device Sequence Number: 16098263
• Product Code: FDE
• UDI-Device Identifier: 10198459183584
• UDI-Public: 10198459183584
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 08/12/2026

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: DYNJ58504F
• Device Lot Number: 24LMC540
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2025
• 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: 03/18/2025
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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