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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH INSULIN SYRINGE 29G-.5CC-1/2" SYRINGE, PISTON

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MHC MEDICAL PRODUCTS, LLC EASYTOUCH INSULIN SYRINGE 29G-.5CC-1/2" SYRINGE, PISTON Back to Search Results
Model Number 829555
Device Problems Bent (1059); Product Quality Problem (1506); Dull, Blunt (2407)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2018
Event Type  malfunction  
Event Description
User had reported issues with a package of syringes. This was the user's 5th pack of syringes opened by the user. 1st issue: "about 3 of needles fold over when inserting into the rubber piece to draw out the insulin. ". 2nd issue: for "a couple of syringes, the rubber plunger isn't tight enough to pull the insulin and air would enter into the syringe. ". 3rd issue: "one of the syringes was missing the rubber plunger. Some of the needles are dull, but not that many. ".
 
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Brand NameEASYTOUCH INSULIN SYRINGE 29G-.5CC-1/2"
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC
11930 kemper springs drive
cincinnati OH 45240
Manufacturer (Section G)
MHC MEDICAL PRODUCTS, LLC.
11930 kemper springs drive
cincinnati OH 45240
Manufacturer Contact
jennifer seiple
11930 kemper springs drive
cincinnati, OH 45240
MDR Report Key7607759
MDR Text Key111308546
Report Number3005798905-2018-02290
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Remedial Action Replace
Type of Report Initial
Report Date 06/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number829555
Device Lot Number44836
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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