MAUDE Adverse Event Report: Medline Industries, LP CENTURION; IV SECUREMENT KIT

Catalog Number	IVS1945
Medical Device Problem Codes	Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "our iv securement kits leaking fluids" and "when he screws on the insyte needle to the pigtail it comes loose even after its tight".
Additional Manufacturer Narrative
The customer reported concerns about iv securement kits leaking fluids and stated that when the insyte needle is screwed on to the pigtail, it comes loose even after it is tight.No sample or photo was received for the investigation; finished good production records were reviewed with no run without approvals, deviations or non-conformance reports, finished good pack build was reviewed with no issues, and trending found 0 additional reported complaints for this issue for the account in the past 6 months.The investigation was limited without a sample and additional information regarding the complaint incident, and the reported problem could not be confirmed.It should be noted that the kit bill of materials does not include a needle component; at this time, the root cause of the reported issue cannot be identified, and this issue will continue to be monitored by centurion's complaint handling 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: CENTURION
• Common Device Name: IV SECUREMENT KIT
• Manufacturer (Section D): Medline Industries, LP; 301 catrell drive; howell MI 48843
• Manufacturer Contact: urmi parekh ; 301 catrell drive; howell, MI 48843
• MDR Report Key: 50693684
• Report Number: 1824619-2026-00034
• Device Sequence Number: 21246267
• Product Code: LRS
• UDI-Device Identifier: 10653160269441
• UDI-Public: 10653160269441
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/09/2026

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: IVS1945
• Device Lot Number: 2022111890
• Was Device Available for Evaluation?: Yes
• 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: 04/21/2023
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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