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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH; SYRINGES
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MHC MEDICAL PRODUCTS, LLC EASYTOUCH; SYRINGES Back to Search Results
Catalog Number 831165
Device Problems Material Too Rigid or Stiff (1544); Dull, Blunt (2407); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2022
Event Type  malfunction  
Event Description
End user reports that the syringes are dull and more force must be used to pierce the skin for use.In addition, when filling the barrel, the plunger will push the insulin out despite proper depressurization of the syringes when filling.
 
Manufacturer Narrative
Initial trend analysis for lot 57012 was conducted, no malfunctions were found.This is the only complaint for lot 57012.Further investigation will be conducted to determine the root cause of complaint.
 
Event Description
End user reports that the syringes are dull and more force must be used to pierce the skin for use.In addition, when filling the barrel, the plunger will push the insulin out despite proper depressurization of the syringes when filling.
 
Manufacturer Narrative
A reserved lot test was conducted on lot 57012 for needle tip condition through projection magnification, no needle tip defect was found.Also, a simulation of liquid draw performation was conducted, resulting in the event occuring's due to the end user's error.No abnormalities or defects found with syringe lot 57012.
 
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Brand Name
EASYTOUCH
Type of Device
SYRINGES
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 Key15825927
MDR Text Key307681455
Report Number3005798905-2022-03085
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 11/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number831165
Device Lot Number57012
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/14/2022
Initial Date FDA Received11/18/2022
Supplement Dates Manufacturer Received11/14/2022
Supplement Dates FDA Received01/09/2023
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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