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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYRINGE SYRINGE, PISTON

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SYRINGE SYRINGE, PISTON Back to Search Results
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem Insufficient Information (4580)
Event Description
I would like to report an unsafe condition with syringes. The naming of the syringes has units, cc and ml. These supplies are sent but the county has caused confusion for both pharmacy techs drawing up the vaccine and nurses who administer. I have pictures if needed. Confusing / incomplete info (label/labeling) packaged measuring device cause for error. (b)(6). Submission id: (b)(4).
 
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Brand NameSYRINGE
Type of DeviceSYRINGE, PISTON
MDR Report Key12869475
MDR Text Key281336495
Report NumberMW5105573
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 Unknown
Type of Report Initial
Report Date 05/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided

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