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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASY TOUCH; SYRINGE
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MHC MEDICAL PRODUCTS, LLC EASY TOUCH; SYRINGE Back to Search Results
Catalog Number 830165
Device Problems Material Separation (1562); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2022
Event Type  malfunction  
Event Description
End user reports syringe cannulas are forked and/or split visibly before use.
 
Manufacturer Narrative
Initial trend analysis for lot 56372 was conducted, no malfunctions were found.This is the only complaint for lot 56372.Further investigation will be conducted to determine the root cause of complaint.
 
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Brand Name
EASY TOUCH
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 Key16040448
MDR Text Key307682166
Report Number3005798905-2022-03091
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 Consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial
Report Date 12/22/2022
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 Number830165
Device Lot Number56372
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/16/2022
Initial Date FDA Received12/22/2022
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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