MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; ANESTHESIA CONDUCTION KIT

Model Number 4824-20

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2022

Event Type  malfunction  

Event Description

The lp (lumbar puncture) needle in the kit leaked fluid around the hub of the luer lock hub of the needle after performing opening pressure.The needle initially worked; i was able to obtain opening pressure using the manometer.After removing the manometer, the spinal fluid leaked around the hub and did not come out of the hub (end of the needle).I was able to obtain samples by catching the fluid, and there was no harm to the patient, but would not have expected the needle to leak at the hub.The needle was not bent and there was no visible damage to the luer lock plastic hub.The kit is the smith medical lumbar puncture tray, adult.

• Brand Name: PORTEX
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 13731770
• MDR Text Key: 287017817
• Report Number: 13731770
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4824-20
• Device Catalogue Number: 4824-20
• Device Lot Number: 4212237
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1