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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 Device Difficult to Setup or Prepare (1487); Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/09/2020
Event Type  malfunction  
Manufacturer Narrative
Device not available for return due to end-user not having any product to return. Production records provided in lieu of testing of returned lot from end-user. No issues were noted in the analysis of the production records. (b)(4).
 
Event Description
When the end-user tries to draw insulin, the plunger gets stuck in the barrel.
 
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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 Key9960033
MDR Text Key192173106
Report Number3005798905-2020-02932
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 04/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number731565
Device Lot Number47947, 47167
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2020
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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