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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD INTEGRA RETRACTING NEEDLE 25G 5/8 (0.5 MM X 16 MM) SYRINGE, PISTON

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BECTON DICKINSON AND COMPANY BD INTEGRA RETRACTING NEEDLE 25G 5/8 (0.5 MM X 16 MM) SYRINGE, PISTON Back to Search Results
Model Number REF 305310
Device Problem Retraction Problem (1536)
Patient Problem Injury (2348)
Event Date 10/05/2017
Event Type  malfunction  
Event Description
After vaccine was administered to patient, the retractable syringe did not retract completely which resulted in a patient receiving a superficial scratch on her thigh when the syringe was being pulled away. The tip of the needle was still outside the hub of the syringe. Pictures available upon request.
 
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Brand NameBD INTEGRA RETRACTING NEEDLE 25G 5/8 (0.5 MM X 16 MM)
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
MDR Report Key6940224
MDR Text Key89373000
Report NumberMW5072679
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 Other Health Care Professional
Type of Report Initial
Report Date 10/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREF 305310
Device Lot Number6048798
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? 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?
Type of Device Usage

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