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

Catalog Number	DYND74261
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "in placing 3-4 ivs per day, i¿ve had only one of the tegaderms (the sterile adhesive patch that goes over the iv site to protect and secure the iv in) actually separate properly from the paper backing the way it¿s supposed to.".
Additional Manufacturer Narrative
The customer reported an adhesive issue dressing, stating that only one of the tegaderms actually separated properly from the paper backing and that when separation failed, they had to go through kit after kit, trying to get one that could be used.Finished good production records and finished good pack build were reviewed, and a sample was received; medline received 3 ea unopened kits, tested 3 ea of the dressings, and 2 ea the paper frame border separated from the dressing itself so they were no longer able to be used, while the 3rd one the paper frame did not detach.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.

• Brand Name: MEDLINE
• Common Device Name: IV START KIT W/CHLORAPREP(R)
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50867615
• Report Number: 1417592-2026-48601
• Device Sequence Number: 10715995
• Product Code: LRO
• UDI-Device Identifier: 40080196859840
• UDI-Public: 40080196859840
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/22/2026

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: DYND74261
• Device Lot Number: 24BBG550
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/05/2024
• 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: 07/26/2024
• Initial Report FDA Received Date: 09/23/2026
• 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