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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 Problem Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/28/2018
Event Type  malfunction  
Manufacturer Narrative
(manufacturer narrative
=
t, corrected data
=
f) (b)(4). Product not returned for evaluation. Advised customer to return to pharmacy for a replacement. Most likely underlying root cause: mlc-140- supplier manufacturing defect. Based on the post market review syr-pmr-100 and review of the fda's total product life cycle (tplc) - total device problems, for possible delay in administration of insulin. Reference - capa (b)(4).
 
Event Description
Customer say 3 of her syringes were bent. Customer is not in need of any medical attention and did not use the syringes. Advised customer to return to pharmacy.
 
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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 Key7970436
MDR Text Key126094824
Report Number1000113657-2018-01043
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 10/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYRINGES
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location Home
Date Manufacturer Received10/12/2018
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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