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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RETRACTABLE TECHNOLOGY VANISHPOINT SYRINGE 3 ML

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RETRACTABLE TECHNOLOGY VANISHPOINT SYRINGE 3 ML Back to Search Results
Model Number 10301
Device Problems Retraction Problem (1536); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 06/21/2016
Event Type  malfunction  
Event Description
Needle did not retract when safety button activated.
 
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Brand NameVANISHPOINT SYRINGE 3 ML
Type of DeviceSYRINGE
Manufacturer (Section D)
RETRACTABLE TECHNOLOGY
little elm TX 75068
MDR Report Key5778314
MDR Text Key49144994
Report NumberMW5063293
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10301
Device Lot NumberA845A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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