MAUDE Adverse Event Report: ICU MEDICAL, INC. PORTEX; ANESTHESIA CONDUCTION KIT

Catalog Number	A4283-18
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was stated that the crna was placing epidural for labor delivery.When he attempted to pull back on the catheter, the catheter broke.Approximately 5 cm of the catheter was left in the patient's back.There were patient involvement and no adverse event reported.
Additional Manufacturer Narrative
H3: the device was received for evaluation.The device history review could not be performed due to logistical issues with the closure of the keene site and their transfer of dhr records.Visual and functional tests were performed, which confirmed the issue of the catheter being severed.The probable cause was unknown.The timeframe of the occurrence could not be determined.No further action was taken.

• Brand Name: PORTEX
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ICU MEDICAL, INC.; 10 bowman drive; keene NH 03431
• Manufacturer Contact: reed covert ; 10 bowman drive; keene, NH 03431 ; 2247062300
• MDR Report Key: 23360409
• Report Number: 1217052-2025-00105
• Device Sequence Number: 12979762
• Product Code: CAZ
• UDI-Device Identifier: 15019517095166
• UDI-Public: (01)15019517095166(17)260430(10)6131011
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K965017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: A4283-18
• Device Lot Number: 6131011
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Race: White