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

Catalog Number	PAIN2304
Medical Device Problem Codes	Connection Problem (2900); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, the epidural catheter disconnected from epidural clamp.The clamp appeared to be properly closed.Due to contamination risk, the epidural had to be removed and a new one was placed.Customer contact stated, "the catheter was not sitting correctly into the connector, so the catheter would become disconnected from the connector".The epidural had to be replaced due to this issue and "no known issues developed".No additional details provided.
Additional Manufacturer Narrative
It was reported that on (b)(6) 2025, the epidural catheter disconnected from epidural clamp.The clamp appeared to be properly closed.Due to contamination risk, the epidural had to be removed and a new one was placed.Customer contact stated, "the catheter was not sitting correctly into the connector, so the catheter would become disconnected from the connector".The epidural had to be replaced due to this issue and "no known issues developed".No additional details provided.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 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
• Manufacturer Contact: sabrina surmaj ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24715844
• Report Number: 1417592-2026-00294
• Device Sequence Number: 20250069
• Product Code: OFT
• UDI-Device Identifier: 10198459478291
• UDI-Public: 10198459478291
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/30/2026
• 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 Age: 28 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Race: Asian