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

Catalog Number	24-1300-22
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the connection between the catheter and filter disconnected when it was being attached.When the user connected the catheter to the filter, she screwed it on.When she did that, the yellow top made a pop sound, and it then very easily disconnected from the filter.The anesthetist had 3 catheters with the same issue all from batch#: 4461203.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: components from two 24-1300-22 nrfit connector, minipack 1, epidural, 16g tuohy ndl, ce3e cath, 10/bx were received without their original packaging for investigation.Customer also provided photos of sample.On photos provided by customer are visible components 30-4498-001 connector, catheter, 19g-21g, (us) 16g-18g (smi), iso 80369-6 and 30-4451 filter, 0.2 micron, iso neuraxial f/m, rotating hub.On the second photo the yellow rotating collar is detached from filter.Samples provided by customer were visually inspected with no problem found, so both of the samples were tested by connecting the filter with the connector and then slightly pulled to see if the filter will detach or not.On first video you can see that the tested sample is connected successfully and then after pulling the components did not detach.On second video, you can see that during the connection of filter and connector, the yellow rotating collar detached from filter.This was probably caused by previous overtightening of connection between filter and connector.As per instructions for use, "overtightening the connection between the epidural catheter connector or epidural needle to the male rotating collar may cause rotating collar to dislodge from filter body".Based on the event description and samples condition the disconnection was probably caused when the customer did not follow the instructions for use.No trend of similar customer complaints has been identified.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX NRFIT CONNECTOR EPIDURAL MINIPAK
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21333073
• Report Number: 3011237704-2025-00020
• Device Sequence Number: 15576825
• Product Code: CAZ
• UDI-Device Identifier: 15019517075335
• UDI-Public: (01)15019517075335(17)270304(10)4461203
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/07/2025

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: 24-1300-22
• Device Lot Number: 4461203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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: Female