MAUDE Adverse Event Report: ICU MEDICAL, INC. PORTEX EPIDURAL NRFIT CONNECTOR, MINIPACK, TUOHY NDL, CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number	24-1301-22
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that the device could not administer to the patient, and the anesthesiologist could not get it to work on the patient.The event occurred when the doctor was about to administer the epidural during use with the patient.All anesthesiologists had more or less issues placing an epidural with the connection depending on the patient.An older version of the device had to be used instead.There was patient involvement, but no injury.
Additional Manufacturer Narrative
Five unused and unopened packages of the device were returned in the original box.As received, no visible defects were observed.Functional testing was performed and the device could be connected without any difficulties.Additionally, connector threads were measured and found to be within drawing specification.It is suspected that the connections were not secured or overtightened, or the catheter was not fully inserted, resulting in the reported issue.Complaint history was reviewed, and no signal of confirmed complaints related to this issue was identified.

• Brand Name: PORTEX EPIDURAL NRFIT CONNECTOR, MINIPACK, TUOHY NDL, CONTINUOUS TRAYS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ICU MEDICAL, INC.; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22849477
• Report Number: 3012307300-2025-09795
• Device Sequence Number: 12862877
• Product Code: CAZ
• UDI-Device Identifier: 15019517073935
• UDI-Public: (01)15019517073935(17)290405(10)6002151
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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 Catalogue Number: 24-1301-22
• Device Lot Number: 6002151
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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 Sex: Unknown