MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V. MEDLINE; CSE TRAY

Catalog Number	PAIN2304
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the epidural catheter disconnected from epidural clamp.Clamp appeared properly closed.Quality issues noted with the connector.The manufacturer's rep discerned that the epidural tubing was not always properly seating into the connector.Due to contamination risk, the epidural had to be removed and a new one was placed.Since the disconnects were often unwitnessed, the catheters were replaced at the patient side.No known issues developed.There were no reports of death, serious injury, or follow up care.
Event or Problem Description
Catheter disconnected.
Additional Manufacturer Narrative
Added h6 (b) investigation types 3331, 4121, 4110, and 4111, but there was no change to findings or conclusion.

• Brand Name: MEDLINE
• Common Device Name: CSE TRAY
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.; blvd world trade center #106; parque industrial oradel; nuevo laredo tamaulipas, 88285 ; MX 88285
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24955899
• Report Number: 1417592-2026-00475
• Device Sequence Number: 10093300
• 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: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: PAIN2304
• Device Lot Number: 25JLA026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2025
• 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
• Patient Sex: Female