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

Device Problems Break (1069); Material Separation (1562); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/18/2020

Event Type  Injury  

Event Description

Epidural catheter used during tka.Upon removal, resistance noted.Catheter broke with approx 4 retained.Pt ultimately had to return to operating room for removal of remaining catheter.Fda safety report id# (b)(4).

• Brand Name: EPIDURAL CATHETER
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.
• MDR Report Key: 10477593
• MDR Text Key: 205334433
• Report Number: MW5096360
• 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
• Type of Report: Initial
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR