MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PERIFIX; EPIDURAL ANESTHESIA SET

Model Number 332220

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2019

Event Type  malfunction  

Event Description

Epidural inserted for surgery.Upon removing catheter after case it was discovered the blue tip was not intact.Discussed with radiologist and recommended lumbar films and ct.7mm of epidural catheter found at l1-2 in epidural space.Discussed case with neurosurgery after ct reviewed stated no intervention needed.Discussed with pt in detail and advised pt to follow up with primary care physician (pcp) should she become symptomatic.

• Brand Name: PERIFIX
• Type of Device: EPIDURAL ANESTHESIA SET
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 8744105
• MDR Text Key: 149501728
• Report Number: 8744105
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 332220
• Device Catalogue Number: 332220
• Device Lot Number: 0061661814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Weight: 64