MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V. MEDLINE; CSE TRAY 17G/27G

Catalog Number	PAIN1781
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the anesthesiologist came with concerns regarding the epidural catheters, having difficulty flushing medication through.Occurred during use, on an unknown date, with no reported injury.The catheter was removed from the patient and they were still unable to flush any fluid through the catheter.There were no reports of death, serious injury, medical intervention, or follow up care.
Event or Problem Description
Unable to flush epidural catheter.
Additional Manufacturer Narrative
Additional information to include h6 (b) type of investigation 3331, 4121, and 4110, but there was no change to findings or conclusion.

• Brand Name: MEDLINE
• Common Device Name: CSE TRAY 17G/27G
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.; blvd world trade center 106; no. 106 parque industrial; nuevo laredo, 88285 ; MX 88285
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24939133
• Report Number: 1417592-2026-00432
• Device Sequence Number: 13429614
• Product Code: OFT
• UDI-Device Identifier: 10195327043360
• UDI-Public: 10195327043360
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: PAIN1781
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown