MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX; CATHETER, CONDUCTION, ANESTHETIC

Model Number UNKNOWN

Device Problems Detachment Of Device Component (1104); Physical Resistance (2578)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/10/2017

Event Type  Injury  

Event Description

During removal of an epidural catheter from the lumbar spine, a portion of the distal tip broke.Approximately 5-6 cm of the distal tip was retained.

• Brand Name: PERIFIX
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 7006136
• MDR Text Key: 91231749
• Report Number: 7006136
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES.
• Patient Age: 34 YR