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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC MEMBERS MARK SYRINGE

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MHC MEDICAL PRODUCTS, LLC MEMBERS MARK SYRINGE Back to Search Results
Catalog Number 730365
Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2021
Event Type  malfunction  
Manufacturer Narrative
When initial trend analysis for lot number 51391 was conducted there were no other complaints for lot number 51391. Additional investigation will be conducted for root cause of complaint.
 
Event Description
End user reports that the units marked on a barrel of one syringe in a box of one hundred are difficult to read. This caused complication in insulin dosage.
 
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Brand NameMEMBERS MARK
Type of DeviceSYRINGE
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 Key11774473
MDR Text Key249457091
Report Number3005798905-2021-03005
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,Followup
Report Date 04/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number730365
Device Lot Number51391
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 Received04/30/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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