MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; KIT,IV START,FRAME DRESSING,LATEX FREE

Catalog Number	DYND74088
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Deformation (2976); Adhesive Too Strong (4071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the tegaderm strips are getting stuck and the tegaderm is getting crumpled up, unable to be used or the tegaderm isn¿t sticking and causing problems with the iv.".
Additional Manufacturer Narrative
The customer reported problems with the iv start kits: the tegaderm strips are getting stuck, the tegaderm is getting crumpled up, unable to be used, or the tegaderm isn¿t sticking and causing problems with the iv.No sample or photo was received for the investigation; finished good production records and finished good pack build were reviewed, and 10 retain samples were visually evaluated and then evaluated for functionality.No samples showed any visual abnormalities, delamination of the liner or frame, or defect in the functioning of these dressings; given this investigation, the complaint cannot be confirmed.The root cause is unidentified and the responsibility is undetermined, and the division 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: KIT,IV START,FRAME DRESSING,LATEX FREE
• 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: 50896662
• Report Number: 1824619-2026-00106
• Device Sequence Number: 10712232
• Product Code: LRS
• UDI-Device Identifier: 10080196992928
• UDI-Public: 10080196992928
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: DYND74088
• Device Lot Number: 2025050690
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/29/2025
• 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: 09/23/2025
• 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