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

Catalog Number	DYND74260
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "defective tagaderm, will not come off the adhesive, not usable.".
Additional Manufacturer Narrative
The customer reported "defective tagaderm, will not come off the adhesive, not usable." a sample was received for investigation, and evaluation found 5 opened iv start kits; all 5 of the dressings received were stuck to the liner backing and the paper frame had separated from the dressing itself so they were no longer usable.Finished good production records and finished good pack build were reviewed, and there were no issues that likely contributed to the reported issue; the reported issue was confirmed.The cause of this 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.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 W/CHLORAPREP APP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50853816
• Report Number: 1417592-2026-47396
• Device Sequence Number: 18626029
• Product Code: LRO
• UDI-Device Identifier: 40080196992981
• UDI-Public: 40080196992981
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: DYND74260
• Device Lot Number: 24BBL165
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/10/2024
• 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: 04/03/2024
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (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