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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH; INSULIN SYRINGE
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MHC MEDICAL PRODUCTS, LLC EASYTOUCH; INSULIN SYRINGE Back to Search Results
Catalog Number 829155
Device Problems Product Quality Problem (1506); Dull, Blunt (2407); Material Deformation (2976); Material Integrity Problem (2978); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2023
Event Type  malfunction  
Manufacturer Narrative
No device returned.Initial trend analysis for lot 56505 was conducted, no malfunctions were found.This is the only complaint for lot 56505.Further investigation will be conducted to determine the root cause of complaint.
 
Event Description
End user reports the insulin syringes from item number 829155 and lot 56505 are dull and must use more force to insert into skin for use.The reporter also mentioned that some of the cannulas are bent before use when removing the cap from the needle.
 
Event Description
End user reports the insulin syringes from item number 829155 and lot 56505 are dull and must use more force to insert into skin for use.The reporter also mentioned that some of the cannulas are bent before use when removing the cap from the needle.
 
Manufacturer Narrative
After reviewing the production process and product testing completed, no malfunctions found.The likely cause of the complaint is due to the removal of the orange protective cap.Per prior tests conducted, it has been confirmed that burrs can occur during the removal of the cap especially because of differences in other brands.
 
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Brand Name
EASYTOUCH
Type of Device
INSULIN 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 Key16315076
MDR Text Key309266467
Report Number3005798905-2023-03097
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130230
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 02/07/2023
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 Number829155
Device Lot Number56505
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/24/2023
Initial Date FDA Received02/07/2023
Supplement Dates Manufacturer Received01/24/2023
Supplement Dates FDA Received03/01/2023
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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