MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 17/25G CSE TRAY

Catalog Number	PAIN1919B
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2025, after achieving loss of resistance while placing an epidural, the catheter was threaded without difficulty, but medications would not flush through the catheter.
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025, after achieving loss of resistance while placing an epidural, the catheter was threaded without difficulty, but medications would not flush through the catheter.The customer stated that they attempted troubleshooting measures (including changing the clamp and slightly pulling back the catheter while repositioning the patient).The customer said that they replaced the catheter with one from a new kit and were able to perform the procedure without incident.The customer stated that they tried to flush the catheter while outside the patient and was unable to flush more than a drop of fluid while pushing with full force.The customer reported there was no serious injury, medical intervention, or follow-up care required related to the reported incident.No additional information is available at this time.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.

• Common Device Name: 17/25G CSE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22530467
• Report Number: 1417592-2025-00341
• Device Sequence Number: 7487826
• Product Code: OFT
• UDI-Device Identifier: 10195327664381
• UDI-Public: 10195327664381
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/17/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: PAIN1919B
• Device Lot Number: 25ALA744
• 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: 06/20/2025
• Initial Report FDA Received Date: 07/17/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 60 KG