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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
Device Problems Material Separation (1562); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2021
Event Type  malfunction  
Manufacturer Narrative
When initial trend analysis was completed for lot numbers 51291, 52141, and 50441, this was the only complaint for all three lot numbers. Further investigation will be conducted for all three lots to find root cause of the complaint.
 
Event Description
End user reports that insulin leaks from syringe in an unidentified area while during use. On another account and possibly another lot of syringes, end user reports that syringe was missing cannula from barrel hub. End user has acquired three different lots of syringes, lot number 51291, lot 52141, and lot 50441.
 
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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 Key11734267
MDR Text Key247600558
Report Number3005798905-2021-03001
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 Inspection
Type of Report Initial,Followup
Report Date 04/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received04/07/2021
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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