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

Catalog Number	DYNJ81354A
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "item arrived with two dark spots on the inside of the pack making it non-sterile.".
Additional Manufacturer Narrative
The account reported finding stains on back table cover, and the complaint transcript stated the item arrived with two dark spots on the inside of the pack making it non-sterile.No sample or photo was received for the investigation; finished good production records and finished good pack build were reviewed, and no issues were identified that would likely contribute to the reported concern.As a result, medline was unable to confirm the presence of a defect during this investigation, and the true root cause of the reported issue could not be accurately determined.The quality team will monitor this issue for trending purposes, and if a sample, photo, and/or additional information becomes available, this complaint will be reopened to be further investigated.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-UNIVERSAL PACK-LF
• 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: 50868055
• Report Number: 1417592-2026-48673
• Device Sequence Number: 13067230
• Product Code: LRO
• UDI-Device Identifier: 10198459134104
• UDI-Public: 10198459134104
• 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): 09/22/2026

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: DYNJ81354A
• Device Lot Number: 25CMI076
• 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: 04/28/2025
• Initial Report FDA Received Date: 09/23/2026
• 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