MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-IR SONO PACK

Catalog Number	DYNDA2365B
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "received custom pack with the outside pouch opened.".
Additional Manufacturer Narrative
The account reported finding open seal.A sample was received for investigation; finished good production records were reviewed and there were no run without approvals, deviations or non-conformance reports that might have had an impact on this issue, the finished good pack build was reviewed and there were no issues with the build that likely contributed to the reported issue, and trending found 0 additional reported complaint(s) for this issue for the account in the past 6 months.The reported problem was confirmed: the pack received was opened on the top and did not appear to be sealed at all, and no other defects or damage was observed.Based on the complaint details this issue was likely caused by a manual error in the sealing process during pack assembly; production and qc managers were notified, feedback will be provided to the build team for awareness and to prevent recurrence in the future, 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: DBD-IR SONO PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rylee rosenberg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50881812
• Report Number: 1417592-2026-49628
• Device Sequence Number: 13450572
• Product Code: LRO
• UDI-Device Identifier: 40193489836449
• UDI-Public: 40193489836449
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: DYNDA2365B
• Device Lot Number: 23DMG285
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/19/2023
• 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: 06/09/2023
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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