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 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.

Manufacturer Narrative

Additional information: h6 corrected data: h1, corrected data: corrected data h1: type of reportable event.

• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section G): NULL
• MDR Report Key: 12579212
• MDR Text Key: 274818868
• Report Number: 3012307300-2021-09767
• 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
• Patient Sequence Number: 1
• Patient Sex: Male