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

Model Number 332079

Device Problems Material Too Rigid or Stiff (1544); Physical Resistance (2578)

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

Event Date 02/14/2017

Event Type  malfunction  

Event Description

During the placement of an epidural catheter the physician reported the catheter met resistance as it was being threaded through the needle.The physician removed the catheter and upon inspection he stated the end of the epidural catheter had a hard "bur".Manufacturer response for epidural catheter, perifix fx continuous epidural anesthesia tray (per site reporter): reporter not aware of response.

• 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: 6379911
• MDR Text Key: 69128765
• Report Number: 6379911
• 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: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: 332079
• Device Catalogue Number: 332079
• Device Lot Number: 0061525163
• Other Device ID Number: CE17TKFC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2017
• 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 Weight: 93