MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; EEC KIT

Catalog Number	DYNDV2574
Medical Device Problem Codes	Difficult to Open or Remove Packaging Material (2922); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the glue on the packaging is not releasing when we try to get to the dressing" and "only half of the paper edge of the dressing is releasing," with "half the paper edge remaining on the patient.".
Additional Manufacturer Narrative
The account reported issues with the transparent dressings that come in the premade iv kits, including that the glue on the packaging is not releasing and only half of the paper edge of the dressing is releasing.Medline's investigation noted that no sample or photo was received, finished good production records were reviewed with no run without approvals, deviations or non-conformance reports that might have had an impact on this issue, and the finished good pack build was reviewed confirming 1 ea of item 28884 drsg trans 2.4x2.8 suresite was present in the kit.The reported problem could not be confirmed; with the information provided medline was unable to confirm the root cause of the issue.Division to monitor 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: EEC KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946605
• Report Number: 1417592-2026-54299
• Device Sequence Number: 10446257
• Product Code: LRO
• UDI-Device Identifier: 10195327320355
• UDI-Public: 10195327320355
• 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): 09/29/2026

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: DYNDV2574
• Device Lot Number: 25AMF575
• 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: 05/28/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown