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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. SYRINGES BLOOD GLUCOSE SYSTEM

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TRIVIDIA HEALTH, INC. SYRINGES BLOOD GLUCOSE SYSTEM Back to Search Results
Model Number SYRINGES
Device Problems Obstruction of Flow (2423); Manufacturing, Packaging or Shipping Problem (2975); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Product not yet returned for evaluation. Customer no longer using our product. Syringes lot# np18123 is part of the recall z-3202-2018. Most likely underlying root cause: mlc-140- supplier manufacturing defect. Note: manufacturer contacted customer on 11/7/2018 in a follow-up call; customer states that she was able to get prescription for another brand of syringes. Customer will no longer be using our syringes.
 
Event Description
Consumer reported complaint for no aspiration of syringes. Customer states that she has 2 boxes of 100 syringes and only two were good. Customer does not feel safe with the syringes and she will try to get them change to different brand. Customer states that she already discarded the syringes most of the syringes. Customer did not have to seek any medical intervention. The opening in the needle did not dispense the medication in the syringes. Customer will not be using this brand anymore she will have her doctor write her a prescription for another brand. Verify lot # np18123. The customer feels well and did not report symptoms. Medical attention is not reported as a result of the actual blood glucose results. The product storage location is undisclosed.
 
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Brand NameSYRINGES
Type of DeviceBLOOD GLUCOSE SYSTEM
Manufacturer (Section D)
TRIVIDIA HEALTH, INC.
2400 nw 55th court
fort lauderdale FL 33309
Manufacturer Contact
karen devincent
2400 nw 55th court
fort lauderdale, FL 33309
954677-920
MDR Report Key8079529
MDR Text Key128402901
Report Number1000113657-2018-01174
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K993017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 11/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYRINGES
Device Lot NumberNP18123
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location Home
Date Manufacturer Received10/23/2018
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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