MAUDE Adverse Event Report: EPIDURAL CATHETER; CATHETER, CONDUCTION, ANESTHETIC

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/12/2022

Event Type  malfunction  

Event Description

At the end of the procedure, anesthesia was removing the epidural catheter and a portion of it appeared to be missing.Under instruction of the anesthesia provider, the patient was taken to pacu after an attempt to locate the missing portion of the catheter.Anesthesia provider informed the patient and visitor with them of the incident.Anesthesia provider ordered a neuro consult and mri of lumbar spine w/o contrast.Patient was taken to next level of care.

• Brand Name: EPIDURAL CATHETER
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• MDR Report Key: 16240603
• MDR Text Key: 308090112
• Report Number: 16240603
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31390 DA
• Patient Sex: Female