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

Catalog Number	DYND74277
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	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that dressing not stay adhered to skin.
Additional Manufacturer Narrative
The account reported finding adhesive issue with dressing, and the complaint transcript states, "dressing not stay adhered to skin." a sample was received for investigation; medline received 5 ea unopened kit,iv start,chloraprep kits, tested all 5 of the dressings returned, and all of them peeled correctly and the paper frame stayed attached to the dressing, with no defects or damage observed.Finished good production records and finished good pack build were reviewed, and no issues were identified that might have had an impact on or likely contributed to the reported issue.Medline was unable to confirm the reported issue with the samples received, was unable to determine the root cause with the dressings that were received, and the quality team 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: KIT,IV START,CHLORAPREP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915932
• Report Number: 1417592-2026-52067
• Device Sequence Number: 20219959
• Product Code: LRO
• UDI-Device Identifier: 40080196850342
• UDI-Public: 40080196850342
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/28/2026

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: DYND74277
• Device Lot Number: 24ABG372
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/01/2024
• 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: 03/26/2024
• 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): 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