MAUDE Adverse Event Report: BECTON DICKINSON & CO. WHITACRE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number 405010

Device Problem Material Puncture/Hole (1504)

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

Event Date 08/06/2014

Event Type  malfunction  

Event Description

Whitacre needle was not sharp enough to puncture skin during lumbar puncture - next whitacre needle went through skin without problem.

• Brand Name: WHITACRE
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BECTON DICKINSON & CO.; one becton drive; franklin lakes NJ 07417 188
• MDR Report Key: 4143573
• MDR Text Key: 4773095
• Report Number: 4143573
• 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: 08/08/2014

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?: Yes
• Device Operator: Invalid Data
• Device Model Number: 405010
• Device Lot Number: 2075210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2014
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 10/06/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2014
• Patient Sequence Number: 1
• Patient Age: 66 YR