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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 Dull, Blunt (2407); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/29/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Case number - (b)(4). Date of incident reported to cardinal: (b)(6) 2018. Date thi was notified: (b)(6) 2018. Product not returned for evaluation. Replaced product provided by pharmacy. Most likely underlying root cause: mlc-140- supplier manufacturing defect.
 
Event Description
Complaint received by the distributor on (b)(6) 2018. Customer complaint that the needles are dull and bent causing it to be painful when taking the shots. Follow-up call was made on (b)(6) 2018 in an effort to ensure the customer products are not dull and bent as previously stated by the customer. I was able to speak to the customer. She did not have to seek any medical attention and is feeling well. The customer gave the syringes back to the pharmacy the first week of (b)(6) 2018. The pharmacy replaced the syringes and the new ones are working. Unable to verify lot number of the old syringes or the new ones and no contact can be made to pharmacy as customer has no information. The customer is satisfied and does not need any further assistance.
 
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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 Key7971066
MDR Text Key123967348
Report Number1000113657-2018-01046
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 Received10/04/2018
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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