MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. BRAUN; PECAN SPINAL TRAY

Lot Number 61404156

Device Problems Bent (1059); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/11/2015

Event Type  Injury  

Event Description

Upon placement of spinal needle through introducer the hub of the spinal needle bent and proceeded to separate from the needle.The needle was retrieved using fluoroscopy under general anesthesia.

• Brand Name: BRAUN
• Type of Device: PECAN SPINAL TRAY
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; bethlehem PA 18018
• MDR Report Key: 4976431
• MDR Text Key: 22387179
• Report Number: MW5045159
• Device Sequence Number: 0
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Report Date: 07/31/2015

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 Expiration Date: 03/31/2016
• Device Lot Number: 61404156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 107