MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG B BRAUN PERIFIX FX CONTINUOUS EPIDURAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT

Model Number CE17TKFCS

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

Event Date 02/14/2024

Event Type  malfunction  

Event Description

Clamp style catheter connector came loose on the braun prefix continuous epidural anesthesia tray tubing resulting in a loss of epidural pain medication during labor.

• Brand Name: B BRAUN PERIFIX FX CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 18783105
• MDR Text Key: 336343456
• Report Number: MW5151989
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CE17TKFCS
• Device Catalogue Number: 332097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic