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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EASYTOUCH; SYRINGE
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EASYTOUCH; SYRINGE Back to Search Results
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Patient Problems Laceration(s) (1946); Needle Stick/Puncture (2462)
Event Date 03/27/2024
Event Type  Injury  
Manufacturer Narrative
No device returned for testing, insufficient information provided.Due to the lot code not being provided, investigation cannot be initiated.No investigation could be completed due to insufficient information collected from end user.
 
Event Description
End user reported a new polybag of syringes had exposed and bent cannulas due to the caps not being fully pressed down.This resulted in a needlestick of the user.At this time the reporter has not provided additional information via phone or email.Item and lot number are unknown at this time.
 
Event Description
End user reported a new polybag of syringes had exposed and bent cannulas due to the caps not being fully pressed down.This resulted in a needlestick of the user.At this time the reporter has not provided additional information via phone or email.Item and lot number are unknown at this time.
 
Manufacturer Narrative
No device returned for testing, insufficient information provided.Due to the lot code not being provided, investigation cannot be initiated.No investigation could be completed due to insufficient information collected from end user.
 
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Brand Name
EASYTOUCH
Type of Device
SYRINGE
Manufacturer Contact
troy smith
8695 seward road
fairfield, OH 45011
MDR Report Key19006515
MDR Text Key338940326
Report Number3005798905-2024-03172
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102178
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Notification
Type of Report Initial,Followup
Report Date 03/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received03/27/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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