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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 10/11/2021
Event Type  malfunction  
Event Description
End user reported that the syringe cannula de-plugged into the insulin vial when the user withdrew the insulin syringe from the insulin vial.
 
Manufacturer Narrative
No device returned for testing. Production records investigated for lot number 50442. The testing showed no indication of abnormalities or malfunction at time of production.
 
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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 Key12816817
MDR Text Key280833662
Report Number3005798905-2021-03023
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 11/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number730365
Device Lot Number50442
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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