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

Catalog Number	24-1302-22
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two syringes have entrained air via the plunger rather than aspirating the saline.The plunger element was too loose inside the barrel when pulled back.The user explained that probably it wouldn¿t have been an issue if using saline for loss of resistance, but if using air, then the air might have expelled ¿vis¿ the plunger element, giving a false end point for loss of resistance, as one can¿t check if the syringe is working beforehand.There was patient involvement, but no human harm reported.
Additional Manufacturer Narrative
Device evaluation: two used samples and eight unused samples were received.Samples were visually and functionally tested and 9 out of 10 samples passed the tests.One used syringe had bubbles appear during the water test.Based on findings during the testing it seemed that the blue silicone part of the plunger may not fit properly to the syringe barrel, which caused the plunger element to be too loose inside the barrel.The customer reported complaint was unable to be confirmed.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX EPIDURAL CONTINUOUS TRAYS
• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21379081
• Report Number: 3011237704-2025-00028
• Device Sequence Number: 3826313
• Product Code: CAZ
• UDI-Device Identifier: 15019517075342
• UDI-Public: (01)15019517075342(17)280718(10)4388672
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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: 24-1302-22
• Device Lot Number: 4388672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• 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