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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC. MEMBER'S MARK INSULIN SYRINGE

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MHC MEDICAL PRODUCTS, LLC. MEMBER'S MARK INSULIN SYRINGE Back to Search Results
Catalog Number 731565
Device Problems Device Difficult to Setup or Prepare (1487); Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/10/2020
Event Type  malfunction  
Event Description
Syringes are pulling in air when drawing in insulin.
 
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Brand NameMEMBER'S MARK
Type of DeviceINSULIN SYRINGE
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC.
8695 seward rd.
fairfield, oh OH 45011
Manufacturer (Section G)
MHC MEDICAL PRODUCTS, LLC.
8695 seward rd.
fairfield, oh OH 45011
Manufacturer Contact
jennifer seiple
8695 seward road
fairfield, oh, OH 45011
MDR Report Key9665329
MDR Text Key178019140
Report Number3005798905-2020-02906
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,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number731565
Device Lot Number45356
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2020
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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