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

Model Number SYRINGES

Device Problems Obstruction of Flow (2423); Manufacturing, Packaging or Shipping Problem (2975); Mechanical Jam (2983)

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

Event Date 10/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product not yet returned for evaluation.Customer no longer using our product.Syringes lot# np18123 is part of the recall z-3202-2018.Most likely underlying root cause: mlc-140- supplier manufacturing defect.Note: manufacturer contacted customer on 11/7/2018 in a follow-up call; customer states that she was able to get prescription for another brand of syringes.Customer will no longer be using our syringes.

Event Description

Consumer reported complaint for no aspiration of syringes.Customer states that she has 2 boxes of 100 syringes and only two were good.Customer does not feel safe with the syringes and she will try to get them change to different brand.Customer states that she already discarded the syringes most of the syringes.Customer did not have to seek any medical intervention.The opening in the needle did not dispense the medication in the syringes.Customer will not be using this brand anymore she will have her doctor write her a prescription for another brand.Verify lot # np18123.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product storage location is undisclosed.

• 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: 8079529
• MDR Text Key: 128402901
• Report Number: 1000113657-2018-01174
• 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: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SYRINGES
• Device Lot Number: NP18123
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 10/23/2018
• 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