MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. PERIFIX®; ANESTHESIA CONDUCTION KIT

Model Number 332150

Device Problems Decrease in Pressure (1490); Defective Device (2588)

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

Event Date 06/04/2018

Event Type  malfunction  

Event Description

During an epidural injection of the lumbar spine 3 separate loss of resistance syringes were found to not work properly.The syringe would not pressurize creating the resistance needed for the procedure.Perifix 8ml lor syringe by braun medical; lot number: 0061545632.

• Brand Name: PERIFIX®
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 7693794
• MDR Text Key: 114174693
• Report Number: 7693794
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 332150
• Device Catalogue Number: 332150
• Device Lot Number: 0061545632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1