MAUDE Adverse Event Report: SMITHS MEDICAL SMITHS MEDICAL PORTEX; SADDLE BLOCK KIT

Model Number NLD-4795-20

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2016

Event Type  malfunction  

Event Description

Spinal needle introducer 19g, 1 1/2 inch hub separated from needle while inserted into pt's back, needle was removed.No harm.Diagnosis or reason for use: spinal anesthesia.

• Brand Name: SMITHS MEDICAL PORTEX
• Type of Device: SADDLE BLOCK KIT
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 6140741
• MDR Text Key: 61437088
• Report Number: MW5066459
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NLD-4795-20
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR