MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD SPINAL ANESTHESIA TRAY ANESTHESIA CONDUCTION KIT

Catalog Number 405637

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 05/18/2020

Event Type  Injury  

Event Description

(b)(6) year old female admitted (b)(6) 2020 for pre-eclampsia and gestational diabetes management. On (b)(6) 2020 due to severe pre-eclampsia goes to operating room for c-section. During spinal epidural tip of needle is noticed to be broken upon removal. Needle send to pathology. The needle was removed (b)(6) by neurologist in the operating room under fluro. Neurologist signed off (b)(6). The patient discharged (b)(6). She was up ambulating with minimal pain per the md note. Fda safety report id #: (b)(4).

• Brand Name: BD SPINAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; franklin lakes NJ 07417
• MDR Report Key: 10100832
• MDR Text Key: 193313185
• Report Number: MW5094740
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 405637
• Device Lot Number: 0001330369
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 05/28/2020 Patient Sequence Number: 1