*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-12 for * manufactured by Becton Dickinson & Co.

Event Text Entries

[4451640] Spinal needle was being used to perform a placental biopsy on patient. When it was time to take the needle out, it could not be removed. The sonographer assisting the physicians attempted to help and then the nurse assisting pushed down on the patient's skin surrounding the needle and it was removed. The needle was inspected for any abnormalities and none were found.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3820092
• MDR Report Key: 3820092
• Date Received: 2014-05-12
• Date of Report: 2014-05-12
• Date of Event: 2014-05-09
• Report Date: 2014-05-12
• Date Reported to FDA: 2014-05-12
• Date Reported to Mfgr: 2014-05-20
• Date Added to Maude: 2014-05-20
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: NEEDLE
• Product Code: GDM
• Date Received: 2014-05-12
• Model Number: *
• Catalog Number: *
• Lot Number: 3282272
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 1 DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECTON DICKINSON & CO
• Manufacturer Address: ONE BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-05-12