MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PERIPHERAL INSERTION KIT

Catalog Number	DYNDV2621A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that it looks like the issue is that the extension set is laid flat and straight from side to side in a way that causes either end to be caught in the csr wrap fold.This causes kinks in either end, which causes the iv fluids to not flow properly.
Additional Manufacturer Narrative
The account reported finding kinked tubing, and the customer reported that the extension set is laid flat and straight from side to side in a way that causes either end to be caught in the csr wrap fold, causing kinks in either end and the iv fluids to not flow properly; the issue did not occur during use and no injury occurred.A photo and a sample were received for investigation; 6 ea samples were received, finished good production records were reviewed, finished good pack build was reviewed, and trending and component trending were reviewed.Per evaluation of the photo and samples received, the reported issue was confirmed.Per the correction to the original investigation, the most likely root cause scenario is that the wrap is smaller than the extension set, causing the set to kink, and there is no current specified method to place the extension set within the wrap to prevent extension set kinks; this issue will continue to be monitored by centurion's complaint system.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: PERIPHERAL INSERTION KIT
• 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: 50917634
• Report Number: 1417592-2026-52345
• Device Sequence Number: 20277804
• Product Code: LRO
• UDI-Device Identifier: 10653160383437
• UDI-Public: 10653160383437
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• 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): 09/25/2026

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: DYNDV2621A
• Device Lot Number: 2025060290
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/15/2025
• 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: 09/16/2025
• 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