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

Model Number SYRINGES

Device Problems Leak/Splash (1354); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product not yet returned for evaluation.Refer customer to the distributor for replacement.Most likely underlying root cause: mlc-140- supplier manufacturing defect.Based on the post market review (b)(4) 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

Pharmacist is calling on behalf of the customer.Pharmacist says that customer brought back in two boxes of true plus syringes.Customer says that syringes are not drawing up insulin and when it does, insulin leaks during injection.Pharmacy wants replacement syringes.Advised customer to contact distributor for replacement syringes.Advised that i will send return envelope for some of the syringes for investigation purposes.

• 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: 7973565
• MDR Text Key: 123966767
• Report Number: 1000113657-2018-01050
• 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: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• 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
• Treatment: SECOND THERAPY