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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD AUTOSHIELD DUO PEN NEEDLE
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BECTON DICKINSON BD AUTOSHIELD DUO PEN NEEDLE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Exposure to Body Fluids (1745); Malaise (2359); Needle Stick/Puncture (2462); Test Result (2695)
Event Date 02/24/2013
Event Type  Injury  
Event Description
The clinician had given an insulin shot to an (b)(6) patient.The needle then stuck the clinician after the shot was administered.As a result, the clinician was required to undergo medical treatment, which caused her white blood cell count to drop and she became ill.
 
Manufacturer Narrative
The sample is not available for evaluation.Without a sample, a root cause for this incident could not be identified.Additional information regarding the incident has been requested.If information is received, a supplemental report will be submitted.(b)(4).
 
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Brand Name
BD AUTOSHIELD DUO PEN NEEDLE
Type of Device
PEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON
1 becton dr.
franklin lakes NJ 07417
Manufacturer Contact
amy bodell
1 becton dr.
franklin lakes, NJ 07417
8015652585
MDR Report Key3802853
MDR Text Key4364537
Report Number2243072-2014-00093
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 04/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/01/2014
Initial Date FDA Received05/01/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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