MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; CSE TRAY

Catalog Number	PAIN2304
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, the tray was being used on l&d patients for a combined spinal/epidural procedure and the catheter could not be inserted fully into the connector.There was no serious injury or follow-up care needed per the facility, but there was delayed/reduced administration since it was just infusing into the bed instead of through the catheter due to the disconnect.
Additional Manufacturer Narrative
According to the facility, the tray was being used on l&d patients for a combined spinal/epidural procedure and the catheter could not be inserted fully into the connector.There was no serious injury or follow-up care needed per the facility, but there was delayed/reduced administration since it was just infusing into the bed instead of through the catheter due to the disconnect.They opened other pain 2304 trays to obtain replacement items.The procedures have been completed and there was no lasting impact to patients.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: CSE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 24022063
• Report Number: 1417592-2026-00023
• Device Sequence Number: 10554780
• Product Code: OFT
• UDI-Device Identifier: 10198459478291
• UDI-Public: 10198459478291
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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: PAIN2304
• Device Lot Number: 25JLA026
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female