MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MAJOR SINGLE BASIN W/GOWNS

Catalog Number	DYNJS3032
Medical Device Problem Codes	Material Puncture/Hole (1504); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the first picture has a pack that was not sealed correctly.The second picture is of a hole in the pack that did not have a hole in the wrapper.".
Additional Manufacturer Narrative
The account reported finding tear here label slipped and hole in back table cover.Two photos and two full unopened packs were received to aid in the investigation; the finished good production records and finished good pack build were reviewed, and there were no line down situations, no run without approvals, deviations, or non-conformance reports, and no issues with the build that likely contributed to the reported issue.Based on the complaint details, photo and sample investigation, and investigation, the tear here label slipped on the pack was confirmed and the reported issue of a hole in the back table cover was confirmed; there was no damage to the breather pouch.Tear here labels sometimes shift after they are adhered due to multiple factors, including high temperatures and humidity during sterilization, incorrect placement during production, and handling during transit and storage; after further evaluation, the pack was determined to have been caught and snagged on an outside source at some point during production, transit, or storage, but the point at which the damage occurred could not be confirmed, and the issue will be monitored 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: MAJOR SINGLE BASIN W/GOWNS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: urmi parekh ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50856067
• Report Number: 1417592-2026-47813
• Device Sequence Number: 9923537
• Product Code: LRO
• UDI-Device Identifier: 40884389408408
• UDI-Public: 40884389408408
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: DYNJS3032
• Device Lot Number: 23FBV389
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/12/2023
• 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: 10/05/2023
• Initial Report FDA Received Date: 09/22/2026
• 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