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	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "suresite dressing is failing in almost every way.".
Additional Manufacturer Narrative
The account reported finding adhesive issue dressing, and the complaint stated the suresite dressing was failing in almost every way.A sample was received; medline received 1 unopened case of kit,iv start,chloraprep applicator, evaluated 16 ea of the kits, and only one kit had a dressing where the paper frame separated from the dressing itself so it was no longer able to be used; 15 ea of the dressings tested peeled correctly.Finished good production records and finished good pack build were reviewed, with no run without approvals, deviations or non-conformance reports that might have had an impact on this issue and no issues with the build that likely contributed to the reported issue.Per the investigation and sample received, the reported issue was confirmed; the cause was identified as deriving 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.

• 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: urmi parekh ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50896764
• Report Number: 1417592-2026-50751
• Device Sequence Number: 14916095
• Product Code: LRO
• UDI-Device Identifier: 40080196992981
• UDI-Public: 40080196992981
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: 23LBB860
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/15/2024
• 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: 03/08/2024
• Initial Report FDA Received Date: 09/25/2026
• 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