MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX NRFIT EPIDURAL CUSTOM KIT; ANESTHESIA CONDUCTION KIT

Catalog Number	24-1000-64
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Investigation is still in progress.
Event or Problem Description
It was stated that nrfit sciatic and femoral nerve catheters were inserted separately on (b)(6) 2025.Both were connected to separate 5 ml per hour pumps.The femoral nerve catheter was completely drained by(b)(6) 2025, but the sciatic nerve catheter was about half drained.Manual bolus administration of the femoral catheter via the existing filter and connector was normal.Extremely high pressure was encountered when attempting to bolus the sciatic nerve catheter.New filter installed and connected, flushed without problem, but after connecting it to the catheter, the same problem occurred: very high pressure and not flushing.Another attempt with a new connector-filter from an epidural pack with the same problem.The patient's catheter appeared to be undamaged and patent upon visual inspection.When the new filter-connector combinations were then initially tested on the new epidural catheter, they flushed the catheter without problem.However, when unlocking and locking the connector, they could no longer flush despite no obvious damage being visible.There was patient involvement.The incident has been reported to the regulatory agency.Nca reference 2025 003 009 501 016 and mhra reference 34982960-aicxml.Associated catheter and minipack complaints documented on (b)(6).
Additional Manufacturer Narrative
This complaint was incorrectly filed under this registration number, please reference mrn 3012307300-2026-00436-00 for details pertinent to this event.

• Brand Name: PORTEX NRFIT EPIDURAL CUSTOM KIT
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane n.; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23512680
• Report Number: 3011237704-2025-00057
• Device Sequence Number: 9613472
• Product Code: BSN
• UDI-Device Identifier: 15019517054651
• UDI-Public: (01)15019517054651(17)290912(10)6056795
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K172410
• 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): 01/21/2026

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: 24-1000-64
• Device Lot Number: 6056795
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown