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

Catalog Number	DYND74271
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tape not sticking, tegaderm also not sticking.
Additional Manufacturer Narrative
The account reported finding tape and dressing adhesive issue; the incident occurred during patient use and no injury occurred.A sample of 60 unopened iv kits were received for evaluation, the tape was applied to multiple materials, including paper, skin, and the countertop, and the dressings were tested on skin; device history records and the pack build were reviewed.No issues were observed with the tape's ability to adhere to any of the surfaces tested, the dressing's adhesive functioned properly with no concerns noted, and neither of the reported issues could be confirmed with the returned samples.No root cause was identified; the division has communicated this issue to the vendor for further analysis and investigation and 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: IV START KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ankitha komirishetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50818993
• Report Number: 1417592-2026-44696
• Device Sequence Number: 18811633
• Product Code: LRS
• UDI-Device Identifier: 10080196098682
• UDI-Public: 10080196098682
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/17/2026

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: DYND74271
• Device Lot Number: 25JBQ093
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/19/2026
• 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: 01/13/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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