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

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.

• Brand Name: SYRINGES
• Type of Device: BLOOD 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 Key: 7971066
• MDR Text Key: 123967348
• Report Number: 1000113657-2018-01046
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K993017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SYRINGES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 10/04/2018
• 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
• Patient Sequence Number: 1