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

Catalog Number	24-1033-22
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product is set up in the system as 16g, however the box on site states 19g.Pictures of the product were provided.The event date is unknown.There was no patient involvement.
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.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 reportable information becomes available.
Additional Manufacturer Narrative
H6: codes: updated.This complaint was investigated based on photos provided by the customer.There was a visible label on the box which is marked with 19 g and on a second photo was a visible unit pack which is also marked with 19 g and contains catheter bag that is marked with 16 g.The manufacturer would like to clarify that there is not an issue with the labeling.The difference arises from regional variations in gauge size terminology.In the united states, the item is labeled as 19g (us metric system), which corresponds to the same size as 16 g (smi ¿ standard metric instruments), the dimensions and functionality of the catheter remain identical.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: PORTEX NRFIT EPIDURAL CATHETERS
• 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: 20358925
• Report Number: 3011237704-2024-00209
• Device Sequence Number: 7208957
• Product Code: CAZ
• UDI-Device Identifier: 15019517069884
• UDI-Public: (01)15019517069884(17)261119(10)4222022
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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: 24-1033-22
• Device Lot Number: 4222022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2021
• 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