MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV START KIT W/CHLORAPREP APP

Catalog Number	DYND74260
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	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the same problem with the tegaderm in the iv start kit: the film is difficult to take off with the tabs, and the film is staying on the backing and not able to be peeled off correctly.A photo and a sample were received; sample evaluation found 3 dressings without the rest of the kits, with 2 dressings returned as just the liners and the 3rd dressing stuck to the liner with the paper frame separated from the dressing so that it could no longer be used.Finished good production records and finished good pack build were reviewed, and there were no run without approvals, deviations or non-conformance reports and no issues with the build that likely contributed to the reported issue.Medline confirmed the vendor and the cause of this issue; the issue derives from the raw materials process when the force between frame liner and the film is too weak, and medline is working with the component manufacturing facility for further evaluation and corrective actions.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.
Event or Problem Description
It was reported that "the film is difficult to take off with the tabs.The film is staying on the backing and not able to be peeled off correctly.".

• Brand Name: MEDLINE
• Common Device Name: IV START KIT W/CHLORAPREP APP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50899162
• Report Number: 1417592-2026-51122
• Device Sequence Number: 18830959
• Product Code: LRO
• UDI-Device Identifier: 40080196992981
• UDI-Public: 40080196992981
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: DYND74260
• Device Lot Number: 24BBL165
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/29/2024
• 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: 03/21/2024
• Initial Report FDA Received Date: 09/25/2026
• 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