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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 827555
Device Problems Product Quality Problem (1506); Dull, Blunt (2407); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978); Material Too Soft/Flexible (4007)
Patient Problems Laceration(s) (1946); Needle Stick/Puncture (2462)
Event Date 06/21/2021
Event Type  malfunction  
Manufacturer Narrative
Production records and trend analysis investigated for lot number 51132. The testing showed no indication of abnormalities or malfunction at time of production.
 
Event Description
An individual reported that the tips of the cannula were either burred or slightly hooked or bent causing extra damage to their veins.
 
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Brand NameEASYTOUCH
Type of DeviceSYRINGE
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 Key12062746
MDR Text Key260012086
Report Number3005798905-2021-03011
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
3005798905
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Remedial Action Inspection
Type of Report Initial
Report Date 06/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number827555
Device Lot Number51132
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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