• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH SYRINGE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MHC MEDICAL PRODUCTS, LLC EASYTOUCH SYRINGE Back to Search Results
Catalog Number 827155
Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978); Scratched Material (3020)
Patient Problem Needle Stick/Puncture (2462)
Event Date 11/05/2021
Event Type  malfunction  
Event Description
A health professional, harm reduction director reported on behalf of the users of the syringes that the cannulas "have bent tips and twisted bevels". The syringes appear damaged directly from the unopened box.
 
Manufacturer Narrative
No device was returned for testing. Initial trend analysis and production records for lot 54732a were inspected, no malfunctioned found, this is the only complaint for lot 54732a.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13047615
MDR Text Key285837487
Report Number3005798905-2021-03027
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 User Facility,Company Representative
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 12/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number827155
Device Lot Number54732A
Was Device Available for Evaluation? No
Date Manufacturer Received11/05/2021
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

-
-