MAUDE Adverse Event Report: B BRAUN MEDICAL INC. PERIFIX FX SPRINGWOUND EPIDURAL CATHETER; ANESTHESIA CONDUCTION KIT

Model Number CE17TFC

Device Problems Insufficient Flow or Under Infusion (2182); Defective Component (2292)

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

Event Date 05/24/2021

Event Type  malfunction  

Event Description

The epidural catheter component of a combined spinal epidural had difficulty infusing during the patient's c section.After testing outside of the patient, it was noted that an infusion port was not working or was clogged.The patient received adequate anesthesia through the spinal epidural.Fda safety report id# (b)(6).

• Brand Name: PERIFIX FX SPRINGWOUND EPIDURAL CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B BRAUN MEDICAL INC.; bethlehem PA 18018
• MDR Report Key: 11998936
• MDR Text Key: 256456952
• Report Number: MW5101878
• Device Sequence Number: 1
• Product Code: CAZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: CE17TFC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 96