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U.S. Department of Health and Human Services

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

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MHC MEDICAL PRODUCTS, LLC EASYTOUCH INSULIN SYRINGE Back to Search Results
Catalog Number 831365
Device Problems Partial Blockage (1065); Complete Blockage (1094); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2020
Event Type  malfunction  
Manufacturer Narrative
Three issues have been identified: too much air inside of syringe, insulin syringe releasing insulin before administering insulin, cannot push plunger down to administer insulin. Issues 1 and 2 have been linked to improper setup of the syringe. Quickly drawing insulin through a 31g syringe led to unwanted air inside the syringe barrel when drawing insulin. Improper setup led to the syringe releasing air, when a user draws insulin before pushing air into the vial, a vacuum is create and will force the insulin out once removed from the vial. Issue 3 has been linked to a cracked gas nozzle during production. The gas nozzle is used to blowout excess silicone. The reduced air pressure form the crack led to excess silicone in the cannula, causing blockages that will make it difficult to draw and deliver insulin.
 
Event Description
Cusomter reported complaining about air inside of syringe, syringes releasing insulin when they go to inject, and difficulty pushing plunger down.
 
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Brand NameEASYTOUCH
Type of DeviceINSULIN 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 Key11429590
MDR Text Key238624783
Report Number3005798905-2020-02929
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
Remedial Action Replace
Type of Report Initial
Report Date 02/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number831365
Device Lot Number50195
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 Received03/04/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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