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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EASY USE SYRINGE 1CC SYRINGE, PISTON

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EASY USE SYRINGE 1CC SYRINGE, PISTON Back to Search Results
Device Problems Fluid Leak (1250); Detachment of Device or Device Component (2907)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/20/2021
Event Type  malfunction  
Event Description
During administration of the vaccine, the syringe detached from the needle when the plunger was pushed. Some of the medication was administered and the remainder ran down the patient's arm. Patient was instructed to wait, so an incident report could be completed. Fda safety report id# (b)(4).
 
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Brand NameEASY USE SYRINGE 1CC
Type of DeviceSYRINGE, PISTON
MDR Report Key11731655
MDR Text Key247726382
Report NumberMW5100998
Device Sequence Number1
Product Code FMF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 04/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
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? No
Type of Device Usage

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