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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 Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/08/2020
Event Type  malfunction  
Event Description
End-user called in stating that he thinks his insulin syringes are not drawing insulin. He stated, " it seems like there is no hole on the syringe. " the end-user is referring to the cannula. The end-user's product has been requested for return, and the box will be replaced so that they still have syringes.
 
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Brand NameMEMBER'S MARK
Type of DeviceINSULIN SYRINGE
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC
8695 seward road
fairfield, oh
Manufacturer (Section G)
MHC MEDICAL PRODUCTS, LLC
8695 seward road
fairfield, oh
Manufacturer Contact
troy smith
8695 seward road
fairfield, oh 
MDR Report Key10072870
MDR Text Key192173424
Report Number3005798905-2020-02936
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 05/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number731565
Device Lot Number47947
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2020
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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