MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL CUSTOM SINGLE SHOT TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number	A3565-17
Medical Device Problem Codes	Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the loss of resistance syringe was faulty.Occlusion of the tip of the syringe did not provide resistance to the plunger being depressed.There was leak in the rubber seal of the plunger.The surgeon noticed this as soon as attached the syringe to the tuohy epidural needle.Set the faulty syringe aside and open a new syringe.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3: device not returned to manufacturer.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
No product samples, pictures, or videos were received for investigation.The complaint of loss of resistance and leakage could not be confirmed by investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history review of the alleged product lot number found no discrepancies or anomalies relevant to the complaint.

• Brand Name: PORTEX EPIDURAL CUSTOM SINGLE SHOT TRAYS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20486720
• Report Number: 1217052-2024-00137
• Device Sequence Number: 4174197
• Product Code: CAZ
• UDI-Device Identifier: 00351688072729
• UDI-Public: (01)00351688072729(17)270131(10)6003326
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: "K965017 "
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: A3565-17
• Device Lot Number: 6003326
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2024
• 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