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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
Device Problems Product Quality Problem (1506); Dull, Blunt (2407); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/04/2022
Event Type  malfunction  
Event Description
End user reported that the plunger in the syringes were difficult to move up and down and seemed dry, lacking silicon while using insulin syringes.The syringes the user is reporting issues with are item number 829155; lot number 50273, expiration date 8/29/2024 and also item number 830355; lot number 54487 expiration date 6/29/2026.The end user also reports while using the same lot number syringes that the needled feel dull when penetrating the skin.
 
Manufacturer Narrative
Initial trend analysis for lots 50273 and 54487 were conducted, no malfunctions were found.This is the only complaint for lots 50273 and 54487.Further investigation will be conducted to determine the root cause of complaint.
 
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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 Key13684881
MDR Text Key289104358
Report Number3005798905-2022-03042
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
Report Date 03/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received02/04/2022
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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