MAUDE Adverse Event Report: EPIDURAL; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Device Problems Inadequacy of Device Shape and/or Size (1583); Defective Device (2588); Improper Flow or Infusion (2954)

Patient Problem Abdominal Pain (1685)

Event Date 03/31/2023

Event Type  malfunction  

Event Description

Patient was not receiving good pain control from epidural, troubleshooting attempted by primary rn and anesthesia team.While wasting remaining cartridge after birth of baby, it was discovered that there was a flaw in the portion of the catheter permanently attached to the cartridge where there was a narrowing, not allowing medication to flow.

• Brand Name: EPIDURAL
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• MDR Report Key: 16714308
• MDR Text Key: 313151099
• Report Number: MW5116517
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: CADD CASSETTE; FENTANYL; ROPIVACAINE
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American