MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MTS LHK-PALMETTO GENERAL HOSP

Catalog Number	60161954
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the packaging on 2 kits were never sealed.".
Additional Manufacturer Narrative
The customer reported finding breather pouch - open/incomplete seal; the complaint transcript states the issue did not occur during use and no injury occurred.A photo was received from the customer to aid in the investigation; the physical sample was not available, and finished good production records, the bill of materials (bom), packaging instructions, trending, and current stock were reviewed.Based on the review of the received photo, medline confirmed a breather pouch had an open/incomplete seal; however, without the availability of the physical sample for review, medline was unable to determine the root cause.The division will monitor this issue for trending purposes, and there has been no change to the reportability decision associated with this complaint.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: MTS LHK-PALMETTO GENERAL HOSP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50882348
• Report Number: 1417592-2026-49675
• Device Sequence Number: 10708307
• Product Code: OEZ
• UDI-Device Identifier: 10193489049091
• UDI-Public: 10193489049091
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/23/2026

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: 60161954
• Device Lot Number: 25GBT242
• 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: 11/19/2025
• Initial Report FDA Received Date: 09/24/2026
• 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