MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; INTERVENTIONAL PACK

Catalog Number	DYNJ31241I
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the lines are not being connected correctly.".
Additional Manufacturer Narrative
The account reported finding incorrect assembly of manifold, and the complaint stated the ir kit inside had lines not being connected correctly.No sample or photo was received for the investigation; finished good production records and finished good pack build were reviewed, and no instances of line downs, runwithouts, deviations, non-conformance reports, or issues were identified that would likely contribute to the reported concern.Without the ability to directly evaluate the affected product or review high-quality, detailed photos, medline was unable to confirm the presence of a defect during this investigation.The cause was unconfirmed, sample required to determine cause, and the quality team will monitor this issue 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: INTERVENTIONAL PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897639
• Report Number: 1417592-2026-50883
• Device Sequence Number: 10705716
• Product Code: OES
• UDI-Device Identifier: 10198459131882
• UDI-Public: 10198459131882
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/24/2026

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: DYNJ31241I
• Device Lot Number: 25CMB171
• 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: 05/23/2025
• Initial Report FDA Received Date: 09/25/2026
• 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