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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 Obstruction of Flow (2423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2018
Event Type  malfunction  
Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Product not returned for evaluation.No replacement product needed at this time.Customer will go to the pharmacy most likely underlying root cause: mlc-140- supplier manufacturing defect.Notre: manufacturer contacted customer (several attempts) in a follow-up call to ensure the customer's condition since the initial call and that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
 
Event Description
Consumer reported complaint for syringe did not aspirate fully.Customer is calling on behalf of her cat.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product storage location is undisclosed.She was not looking to get a replacement she just wanted us to know about the issue.Wanted to let us know that the syringes that she has for her animal will not aspirate the insulin.About 6 syringes did this.It did not cause any harm to the animal the customer just wanted us to know for our quality control.I advised that we could not replace the syringes and to go to the pharmacy for replacement since we cannot ship that item in the mail.
 
Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4) inspected returned syringes.Syringes aspirated and dispensed liquid substance properly.Plunger functions as intended.No defect found.Most likely underlying root cause: mlc -61- improper use/mishandled by end user.Notre: manufacturer contacted customer (several attempts) in a follow-up call to ensure the customer's condition since the initial call and that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
 
Event Description
Consumer reported complaint for syringe did not aspirate fully.Customer is calling on behalf of her cat.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product storage location is undisclosed.She was not looking to get a replacement she just wanted us to know about the issue.Wanted to let us know that the syringes that she has for her animal will not aspirate the insulin.About 6 syringes did this.It did not cause any harm to the animal the customer just wanted us to know for our quality control.I advised that we could not replace the syringes and to go to the pharmacy for replacement since we cannot ship that item in the mail.
 
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Brand Name
SYRINGES
Type of Device
BLOOD GLUCOSE SYSTEM
Manufacturer (Section D)
TRIVIDIA HEALTH, INC.
2400 nw 55th court
fort lauderdale FL 33309
MDR Report Key8073921
MDR Text Key128478739
Report Number1000113657-2018-01163
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberSYRINGES
Device Lot NumberNP18053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2018
Was the Report Sent to FDA? No
Event Location Home
Date Manufacturer Received10/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SECOND THERAPY; SECOND THERAPY
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