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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 731165
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 11/14/2022
Event Type  malfunction  
Event Description
End user reports that the needles of her syringes were bent before piercing her skin.While gathering information, the end user made mhc aware that the reason for the needle bending is due to the way in which the syringe is being inserted into the insulin vial.The syringe is being inserted directly into the vial with no angle.The end user was educated on an acceptable way to draw insulin from an insulin vial to not damage the syringes.
 
Manufacturer Narrative
Production records investigated for lot number 55292.The testing showed no indication of abnormalities or malfunction at time of production.
 
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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 Key15825767
MDR Text Key307681749
Report Number3005798905-2022-03083
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 11/17/2022
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 Number731165
Device Lot Number55292
Was Device Available for Evaluation? No
Date Manufacturer Received11/14/2022
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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