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

Catalog Number	DYNDV1801C
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Unintended Loss of Vascular Access (4867)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tape adhesive is compromised, making it unusable.
Additional Manufacturer Narrative
The customer reported that staff found the tape adhesive is compromised, the tape was not usable, and in other cases led to loss of iv access for patients due to inadequate securement, resulting in additional iv placement and delays in treatment.A sample consisting of two unopened packs and fourteen individual tapes was evaluated; finished good production records were reviewed with no non-conformances noted, the finished good pack build was reviewed, and complaint trending was reviewed.The sample provided demonstrated multiple tapes with partial lifting, and adhesive performance testing confirmed that some of the tapes were unable to properly adhere and remain attached, confirming the reported issue.As this tape is not manipulated prior to placement within the pack, the issue has been determined to be a vendor product issue relating to the component manufacturing process, and the complaint has been provided to the component manufacturing facility for further evaluation.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: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50916984
• Report Number: 1417592-2026-52252
• Device Sequence Number: 20175799
• Product Code: LRS
• UDI-Device Identifier: 10198459042164
• UDI-Public: 10198459042164
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/25/2026

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: DYNDV1801C
• Device Lot Number: 25JBK963
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/24/2026
• 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: 02/11/2026
• Initial Report FDA Received Date: 09/28/2026
• 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