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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 Problems Crack (1135); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/03/2020
Event Type  malfunction  
Manufacturer Narrative
Product was not returned for testing.In lieu of testing, production records have been attached and analyzed.
 
Event Description
End-user called in reporting that "1-2 packs of syringes out of every 3 boxes they've purchased where the syringe doesn't have suction to pull the insulin." the end-user did not have any products left to return for testing to see what the issue might be.
 
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Brand Name
MEMBER'S MARK
Type of Device
INSULIN 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 Key10112746
MDR Text Key202392521
Report Number3005798905-2020-02939
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112789
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 05/27/2020
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 Number731565
Device Lot Number47166
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/03/2020
Initial Date FDA Received06/02/2020
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
Patient Sequence Number1
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