MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-GENERAL PLASTIC PACK-LF

Catalog Number	DYNJ52449A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the light handle covers are smashed and already opened in the pack and sometimes they don¿t even have the paper lid in the pack from the light handle covers.".
Additional Manufacturer Narrative
The account reported finding damaged light handle covers.Photos were received as a sample to aid in the investigation, finished good production records were reviewed, and a review of the pack build was completed.Based on the complaint details, photo evaluation, and investigation, the reported issue was confirmed.The item was either damaged prior to placement in the pack and was not noted during assembly or the item became damaged due to rough handling of the pack; the issue will be reported to the supplier quality team, and the 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-GENERAL PLASTIC PACK-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdulrahim ghaffar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50757414
• Report Number: 1417592-2026-39706
• Device Sequence Number: 9551057
• Product Code: FTN
• UDI-Device Identifier: 40195327038145
• UDI-Public: 40195327038145
• 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): 09/14/2026

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: DYNJ52449A
• Device Lot Number: 23IBV427
• 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: 01/04/2024
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown