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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUC; INSULIN SYRINGE
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MHC MEDICAL PRODUCTS, LLC EASYTOUC; INSULIN SYRINGE Back to Search Results
Catalog Number 831365
Device Problems Device Difficult to Setup or Prepare (1487); No Pressure (2994)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/28/2020
Event Type  malfunction  
Event Description
End-user sent an email stating that, " the issue we are having with this specific batch is that when we are drawing up the medication, the seal from the inner plunger does not hold and the doctor is having to use 2 syringes for every 1 because the medication will not draw up." the product was requested for return in order to test it and understand that malfunction that might be occuring.By the end-user's description, it seems the gasket might not be creating a seal in the barrel to allow liquid to be drawn into the barrel.
 
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Brand Name
EASYTOUC
Type of Device
INSULIN SYRINGE
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC
8695 seward road
fairfield, oh
Manufacturer (Section G)
MHC MEDICAL PRODUCTS, LLC
8695 seward road
fairfield, oh
Manufacturer Contact
troy smith
8695 seward road
fairfield, oh 
MDR Report Key10195586
MDR Text Key204719525
Report Number3005798905-2020-02954
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 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number831365
Device Lot Number50195
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/17/2020
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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