MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. EPIDURAL CATHETER; CATHETER, CONDUCTION, ANESTHETIC

Model Number 04046963178399

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/19/2022

Event Type  malfunction  

Event Description

Yellow hub that snaps onto epidural catheter was found to be disconnected from epidural catheter by pt's sister in law (support person) and was unclamped.Fda safety report id# 622295.See scanned pages.

• Brand Name: EPIDURAL CATHETER
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; bethlehem PA 18018 3524
• MDR Report Key: 15002764
• MDR Text Key: 295905264
• Report Number: MW5110818
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• 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: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04046963178399
• Device Lot Number: 061825979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White