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

Lot Number ENDING IN 7879

Device Problems Kinked (1339); Failure to Infuse (2340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2016

Event Type  malfunction  

Event Description

We noticed a pattern of damaged epidural catheters within the same lot number (ending in 7879).After placement of the epidural catheter it was found that these were defective with a kink and unable to inject through them.These catheters were removed from the patients and new ones reinserted.No patients were harmed during these placements.When we discovered the pattern, i notified materials management.We removed the defective trays from service and a rush order was placed for trays to replace lot #7879.Anesthesia staff was informed of the defect and were advised to examine catheters prior to placement for the defect and spare catheters were supplied if needed (none were needed).The new trays arrived before 1500.There was no delays in care or patient harm.It is my understanding that these defective trays were returned to b braun but i am not 100% sure about that.We appreciate the efforts of materials management staff in fixing this quickly and safely!.

• 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: 6442327
• MDR Text Key: 71137770
• Report Number: 6442327
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Lot Number: ENDING IN 7879
• Other Device ID Number: PERIFIX EPIDURAL TRAY YELLOW
• 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: 03/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1