MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; UNIVERSAL BLOCK TRAY

Catalog Number	DYNJRA1785A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that visually we are seeing that the package liner inside is being ripped/torn from packaging or delivery.This technically is breaking sterile especially if we were to take it out of the package to lay on top of our table for the physicians to use.
Additional Manufacturer Narrative
The account reported finding damaged wrap, and the customer stated the issue involved the package liner inside being ripped/torn from packaging or delivery.A photo was received and the customer provided photos for review; finished good production records and the finished good pack build were reviewed, and the photos showed a rip in the csr wrap.Based on the complaint details, photo evaluation, and investigation, the complaint is confirmed.The root cause for the reported issue is pack design.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: UNIVERSAL BLOCK TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50612845
• Report Number: 1417592-2026-32332
• Device Sequence Number: 10634473
• Product Code: OFT
• UDI-Device Identifier: 10193489925036
• UDI-Public: 10193489925036
• 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): 09/02/2026

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: DYNJRA1785A
• Device Lot Number: 25IMC419
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown