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

Catalog Number	DYND74083
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it doesn¿t separate from the backing when we try, it has happened 10 times today at least.".
Additional Manufacturer Narrative
The account reported finding adhesive issue with dressing, and the complaint stated that it "doesn¿t separate from the backing" and "has happened 10 times today at least." medline received a sample for investigation, but the tracking for the shipping label showed that the sample was delivered and it could not be located for evaluation; finished good production records and finished good pack build were reviewed, with no run without approvals, deviations or non-conformance reports and no build issues that likely contributed.Component trending was reviewed and there have been 60 additional reported complaints for this issue for the component in the last 6 months; due to the sample not being located for evaluation, medline was unable to confirm the reported issue.Although the reported issue could not be confirmed without a sample, due to other reports received, the likely root cause is a vendor issue relating to their manufacturing process, and medline is working with the component manufacturing facility for further evaluation and corrective actions 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: cyrus johnson ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947175
• Report Number: 1417592-2026-54409
• Device Sequence Number: 21220504
• Product Code: LRS
• UDI-Device Identifier: 40080196772910
• UDI-Public: 40080196772910
• 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): 09/18/2026

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: 24ABS143
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/26/2024
• 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: 03/19/2024
• Initial Report FDA Received Date: 09/30/2026
• 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