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

Lot Number 61515181

Device Problems Break (1069); Detachment Of Device Component (1104); Sticking (1597); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2017

Event Type  malfunction  

Event Description

Certified registered nurse anesthesiologist (crna) inserted an epidural catheter and when attempting to thread the catheter, met resistance.Attempted to pull epidural catheter out of needle, end of the catheter was broken off.Removed needle and the tip of the catheter that had broken off was stuck in the epidural needle.No harm to patient.

• Brand Name: UNKNOWN
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 6848280
• MDR Text Key: 85135801
• Report Number: 6848280
• 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: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 61515181
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2017
• 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
• Patient Age: 18 YR
• Patient Weight: 84