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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH; SYRINGE
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MHC MEDICAL PRODUCTS, LLC EASYTOUCH; SYRINGE Back to Search Results
Catalog Number 829155
Device Problems Material Frayed (1262); Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2022
Event Type  malfunction  
Manufacturer Narrative
Initial trend analysis for lot 56711a was conducted, no malfunctions were found.This is the only complaint for lot 56711a.Further investigation will be conducted to determine the root cause of complaint.
 
Event Description
End user reports feelings burrs on the needle as well as being able to easily remove the plunger from the barrel.
 
Manufacturer Narrative
No device was returned for testing.Retained lot number 56711a investigated and no malfunctions were found during inspection.No abnormalities were detected.
 
Event Description
End user reports feelings burrs on the needle as well as being able to easily remove the plunger from the barrel.
 
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Brand Name
EASYTOUCH
Type of Device
SYRINGE
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC
8695 seward road
fairfield OH 45011
Manufacturer (Section G)
MHC MEDICAL PRODUCTS, LLC
8695 seward road
fairfield OH 45011
Manufacturer Contact
troy smith
8695 seward road
fairfield, OH 45011
MDR Report Key15825571
MDR Text Key307681965
Report Number3005798905-2022-03088
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 Replace
Type of Report Initial,Followup
Report Date 11/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number829155
Device Lot Number56711A
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/17/2022
Was Device Evaluated by Manufacturer? No
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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