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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODCUTS, LLC. MVP INSULIN SYRINGE

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MHC MEDICAL PRODCUTS, LLC. MVP INSULIN SYRINGE Back to Search Results
Catalog Number 819550
Device Problems Fluid Leak (1250); Device Difficult to Setup or Prepare (1487); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2018
Event Type  malfunction  
Event Description
Syringes are not drawing up insulin, plunger is difficult to draw back, and needles dislodges from barrel.
 
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Brand NameMVP
Type of DeviceINSULIN SYRINGE
Manufacturer (Section D)
MHC MEDICAL PRODCUTS, LLC.
8695 seward road
fairfield OH 45011
Manufacturer (Section G)
MHC MEDICAL PRODCUTS, LLC.
8695 seward road
fairfield OH 45011
Manufacturer Contact
jennifer seiple
8695 seward road
fairfield, OH 45011
MDR Report Key8391234
MDR Text Key137851956
Report Number3005798905-2018-02800
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 01/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number819550
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2018
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

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