MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY WHITACRE NEEDLE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Device Problem Break (1069)

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

Event Date 05/17/2020

Event Type  malfunction  

Event Description

The md did a standard approach for spinal.The patient was able to keep her epidural for both the c-section and for the foreign body removal, so she did not have to have an additional anesthetic.Doctor has saved both parts of the needle and has the package and lot numbers to send to the company to determine if there is any equipment malfunction.Let me know if you need any additional information.

• Brand Name: WHITACRE NEEDLE
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10137435
• MDR Text Key: 194624168
• Report Number: 10137435
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/05/2020,05/26/2020

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: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11680 DA