MAUDE Adverse Event Report: BD WHITACRE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number BD 27 G WHITACRE SPINAL NEEDLE

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 11/06/2014

Event Type  No Answer Provided  

• Brand Name: WHITACRE
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BD; 5859 farinon dr ste 200; san antonio TX 78249
• MDR Report Key: 4331610
• Report Number: 4331610
• Device Sequence Number: 1
• Product Code: BSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Device Model Number: BD 27 G WHITACRE SPINAL NEEDLE
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/11/2014
• Patient Sequence Number: 1