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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 731365
Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/16/2023
Event Type  malfunction  
Event Description
End user reports complete blockage with insulin syringes.End user uses lantus and lispro insulin and has not reported this problem in the past.
 
Manufacturer Narrative
Initial trend analysis for lot 55294 was conducted, no malfunctions were found.This is the only complaint for lot 55294.Further investigation will be conducted to determine the root cause of complaint.
 
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Brand Name
MEMBERS MARK
Type of Device
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 Key16186457
MDR Text Key308265690
Report Number3005798905-2023-03094
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 Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial
Report Date 01/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number731365
Device Lot Number55294
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/16/2023
Initial Date FDA Received01/17/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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