MAUDE Adverse Event Report: Centurion Medical Products, LP CENTURION; DBD-YNHH PEDIATRIC LINE CHANGE TRAY

Catalog Number	LC205
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that needless connector leaked when used.
Additional Manufacturer Narrative
The customer reported finding connector leaked in the dbd-ynhh pediatric line change tray.A sample was received; medline received 1 ea needless syringe without the rest of the pack, observed no damage during physical inspection, reviewed finished good production records and finished good pack build, and found no issues with the build that likely contributed to the reported issue.Medline was unable to re-create the issue because it was not noted what kind of liquid was being used when the syringe leaked, and per the sample received, medline was unable to confirm the reported issue.Based on the complaint details the root cause is considered to be a vendor product issue relating to the component manufacturing process; the complaint was provided to the vendor for further evaluation and supplier quality 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: CENTURION
• Common Device Name: DBD-YNHH PEDIATRIC LINE CHANGE TRAY
• Manufacturer (Section D): Centurion Medical Products, LP; 301 cartrell drive; howell MI 48843 -170
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50900047
• Report Number: 1824619-2026-00109
• Device Sequence Number: 5829677
• Product Code: OFF
• UDI-Device Identifier: 10653160990123
• UDI-Public: 10653160990123
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: LC205
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/08/2023
• 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: 03/02/2023
• Initial Report FDA Received Date: 09/25/2026
• 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