MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT

Model Number CE18HK

Device Problems Break (1069); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/26/2022

Event Type  Injury  

Event Description

First attempt to place epidural resulted in complications - epidural space was accessed with minimal difficulty after adjusting patient position, and catheter was threaded into the space without difficulty or resistance.As needle was slowly removed after catheter placement, with very slight resistance as it was retracted through the patient's ligaments, i felt a distinct pop in the hand that was supporting the epidural catheter, and upon removal of the catheter following this pop discovered the distal portion had sheared off during needle removal.Fda safety report id (b)(4).

• Brand Name: PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 15310927
• MDR Text Key: 298936134
• Report Number: MW5111743
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: CE18HK
• Device Lot Number: 0061828557
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American