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

Catalog Number	DYND74083
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "defective dressing in the kits.It's very sticky and too hard to pull off and the dressing sticks to it making it unusable.".
Additional Manufacturer Narrative
The account reported finding the dressing was very sticky and too hard to pull off, and the dressing sticks to it making it unusable.A sample was received; medline received 6 boxes of unopened iv start kits, evaluated a kit from each of the boxes received, peeled the paper backing off of the dressing with no tearing and no issue applying it to skin, reviewed finished good production records, and reviewed the finished good pack build.Per the complaint details and the sample received, medline was unable to confirm the reported issue due to no functional or visual defects being observed during evaluation and testing of the samples received.The cause was not confirmed with received sample, and the division will monitor 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: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50807641
• Report Number: 1417592-2026-43983
• Device Sequence Number: 10610644
• Product Code: LRS
• UDI-Device Identifier: 40080196772910
• UDI-Public: 40080196772910
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: DYND74083
• Device Lot Number: 23KBT025
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/05/2024
• 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: 01/03/2024
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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