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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FEEL TECH BIO CO., LTD. EASYTOUCH; INSULIN SYRINGE
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FEEL TECH BIO CO., LTD. EASYTOUCH; INSULIN SYRINGE Back to Search Results
Catalog Number 830155
Device Problems Product Quality Problem (1506); Material Too Rigid or Stiff (1544); Dull, Blunt (2407); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2023
Event Type  malfunction  
Manufacturer Narrative
Initial trend analysis for lot 60702a was conducted, no malfunctions were found.This is the only complaint for lot 60702a.Further investigation will be conducted to determine the root cause of complaint.
 
Event Description
End user reports that the syringe from lot 60702a are different in appearance than syringes purchased in the past.User describes the plunger is easily removed from the barrel,the cannula is dull and the end caps do not fit properly which caused a few caps to fall off inside of the polybag.End user did not communicate after several attempts as to which side of the syringe the cap was off inside of the polybag.
 
Manufacturer Narrative
Cmo inspected retained lot 60702a, no abnormalities were found during testing.
 
Event Description
End user reports that the syringe from lot 60702a are different in appearance than syringes purchased in the past.User describes the plunger is easily removed from the barrel,the cannula is dull and the end caps do not fit properly which caused a few caps to fall off inside of the polybag.End user did not communicate after several attempts as to which side of the syringe the cap was off inside of the polybag.
 
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Brand Name
EASYTOUCH
Type of Device
INSULIN SYRINGE
Manufacturer (Section D)
FEEL TECH BIO CO., LTD.
1079-20, charyeongggogae-ro
gwangdeok-myeon, chungcheongnamdo 31223
KS  31223
Manufacturer (Section G)
FEEL TECH BIO CO., LTD.
1079-20, charyeongggogae-ro
gwangdeok-myeon, chungcheongnamdo 31223
KS   31223
Manufacturer Contact
troy smith
8695 seward road
fairfield, OH 45011
MDR Report Key18176954
MDR Text Key328634802
Report Number3005798905-2023-03148
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 11/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number830155
Device Lot Number60702A
Was Device Available for Evaluation? No
Date Manufacturer Received11/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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