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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); Muscle/Tendon Damage (4532)
Event Date 06/22/2021
Event Type  malfunction  
Manufacturer Narrative
Production records and trend analysis investigated for lot number 51131.The testing showed no indication of abnormalities or malfunction at time of production.
 
Event Description
The end user reported to the distributor that the "bevel pulls when the syringe is being removed from the arm which causes extra damage to the vein".
 
Manufacturer Narrative
Device not returned for testing.Production records and trend analysis investigated for lot number 51131.The testing showed no indication of abnormalities or malfunction at time of production.
 
Event Description
The end user reported to the distributor that the "bevel pulls when the syringe is being removed from the arm which causes extra damage to the vein".
 
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Brand Name
EASYTOUCH
Type of Device
SYRINGE
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC
8695 seward road
fairfield OH 45011
MDR Report Key12062708
MDR Text Key260012348
Report Number3005798905-2021-03012
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K102178
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 06/26/2021
1 Device was Involved in the Event
1 Patient was 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 Lay User/Patient
Device Catalogue Number827555
Device Lot Number51131
Date Manufacturer Received06/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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