MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE CONVENIENCE KIT; CSE-TUOHY17GX3.5/WHITACRE25GX5

Catalog Number	PAIN1903B
Medical Device Problem Codes	Failure to Deliver (2338); Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility on (b)(6) 2026, after placement we couldn't inject the test dose via the epidural catheter.3x attempts with high pressure were unsuccessful with different syringes.The change of the connecting device wasn't successful either.The catheter was therefore removed, and a new medline cse kit was used making sure that the catheter is patent before placement.
Additional Manufacturer Narrative
According to the facility on (b)(6) 2026, after placement we couldn't inject the test dose via the epidural catheter.3x attempts with high pressure were unsuccessful with different syringes.The change of the connecting device wasn't successful either.The catheter was therefore removed and a new medline cse kit was used making sure that the catheter is patent before placement.The facility continued to state, "initially the catheter could be pushed into the connector up to the black marking.This is not possible anymore.There is some small amount of fluid coming out of the side ports of the catheter with very high pressure which is a minimal amount in comparison to a functioning catheter of this type".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.
Additional Manufacturer Narrative
Update to h3: device evaluated by manufacturer?.

• Brand Name: MEDLINE CONVENIENCE KIT
• Common Device Name: CSE-TUOHY17GX3.5/WHITACRE25GX5
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24606489
• Report Number: 1417592-2026-00224
• Device Sequence Number: 21425771
• Product Code: OFT
• UDI-Device Identifier: 10195327628529
• UDI-Public: 10195327628529
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: PAIN1903B
• Device Lot Number: 25KLA231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2025
• 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: Unknown