MAUDE Adverse Event Report: NULL; ANESTHESIA CONDUCTION NEEDLE

Model Number NEPI-49663C-25

Device Problem Product Quality Problem (1506)

Patient Problem Numbness (2415)

Event Type  malfunction  

Manufacturer Narrative

No product was returned for investigation.No dhr review was done as a lot was not provided.

Event Description

It was reported that the or reported that follow the use of the kit, there was prolonged residual sensory impairment with the numbing lasting 3 times longer than it should.The patient had no feeling and were wetting themselves.Anesthesia staff believed the issue was bupivacaine and are removing it from the kits.

• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section G): NULL
• MDR Report Key: 12579151
• MDR Text Key: 274817475
• Report Number: 3012307300-2021-09765
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEPI-49663C-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male