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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE 30GX5MM
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BECTON DICKINSON AND CO. BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE 30GX5MM Back to Search Results
Catalog Number 329705
Health Effect - Clinical Codes Injury (2348); Needle Stick/Puncture (2462)
Date of Event 10/03/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Results - a sample is not available for investigation.A review of the device history record cannot be completed as the lot number was not provided for this incident.Conclusion - without a sample, an absolute root cause for this incident cannot be determined.
 
Event or Problem Description
It was reported that the health care professional was assisting in giving an injection to the patient with the suspect device.After use the safety mechanism did not activate and the health care professional's finger touched the point of the shield, resulting in a needle stick injury.
 
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Brand Name
BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE 30GX5MM
Common Device Name
PEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
MDR Report Key6037507
Report Number9616656-2016-00068
Device Sequence Number13657589
Product Code FMI
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K110703
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other,use
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 10/18/2016
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? Yes
Operator of Device Health Professional
Device Catalogue Number329705
Device Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/04/2016
Initial Report FDA Received Date10/18/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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