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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 830165
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/17/2023
Event Type  malfunction  
Manufacturer Narrative
Initial trend analysis for lot 58192a was conducted, no malfunctions were found.This is the only complaint for lot 58192a.Further investigation will be conducted to determine the root cause of complaint.
 
Event Description
End user reports that the syringes purchased from amazon are unlike the syringes purchased in the past.In comparison, the syringes user currently has 830165 with lot number 58192a, the plunger has easily be pulled out and the plunger caps are different sizes than previous boxes of syringes.
 
Event Description
End user reports that the syringes purchased from amazon are unlike the syringes purchased in the past.In comparison, the syringes user currently has 830165 with lot number 58192a, the plunger has easily be pulled out and the plunger caps are different sizes than previous boxes of syringes.
 
Manufacturer Narrative
The affected device was returned to cmo on 5-25-2023 and tested for any irregularities.The cmo returned the testing results on 6-9-2023, results as follows; no non-conformities found during testing of physical device or reserved lot testing.Cmo found no plunger glide issues or visual issues.
 
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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 Key16818302
MDR Text Key314054447
Report Number3005798905-2023-03112
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 04/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number830165
Device Lot Number58192A
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/17/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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