• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON LAB DRAW NEEDLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON LAB DRAW NEEDLE Back to Search Results
Lot Number 17B28
Device Problem Insufficient Information (3190)
Patient Problems Burning Sensation (2146); Dysphasia (2195); Shaking/Tremors (2515)
Event Date 08/30/2017
Event Type  Injury  
Event Description
Dr. (b)(6), neurologist, ordered lab work during a consultation in her office at (b)(6) on wednesday, (b)(6) 2017 at 9:00am appointment. I checked in at the (b)(6) affiliated with (b)(6) for lab work with at 10:39 am the same day after the neurology appointment. Due to a tremor in my right hand and arm already, the tech took blood from my left arm. I felt a burning sensation from the needle go down my left arm to my wrist during and after the lab draw. The needle felt like it went deeper than it should or something. The two tech nervously laughed. My body goes into tremors during lab draws. A tech draws the blood and a second tech has to hold me still because of the tremors. After the lab work was completed, my speech was worse than what it already is and my walking/gait worsened too. I called dr. (b)(6) office and spoke to a nurse. Dr (b)(6) would not see me and was advised to go to the emergency room at (b)(6). I also called the (b)(6) clinic within the hour of leaving and was advised to call dr. (b)(6) office (which i had done) and go to the emergency room at (b)(6). I went to the emergency room at (b)(6) (b)(6) 2017; seen by (b)(6), pa who ordered ct scan; told everything was fine with ct scan. Spoke with (b)(6) ombudsman and (b)(6) administration.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLAB DRAW NEEDLE
Type of DeviceNEEDLE
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key6845287
MDR Text Key85145196
Report NumberMW5071973
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2020
Device Lot Number17B28
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

Patient Treatment Data
Date Received: 09/06/2017 Patient Sequence Number: 1
-
-