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

Model Number SYRINGES

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product returned and evaluated with no defect found mlurc - manufacturing deficiency 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).Note: manufacturer contacted customer on (b)(6) 2016 in a follow-up call to ensure that the replacement products resolved the initial concern; customer has received the new the product.Customer stated that they have returned the alleged defective product.Product sent resolved customers initial issue.Customer stated they are satisfied and comfortable with the syringes from the new product replacement.

Event Description

Customer called in requesting a replacement box of syringes.Customer stated that there was only one syringe that was 50 cc.The customer stated that he purchased a box of 3/10 cc.The customer stated that he noticed after using the 50 cc syringe was much larger than the 3/10 cc, he used this syringe on his dog.He stated that the box was completely sealed.He was on his way to the vet to make sure his dog was okay.

• 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: 7986469
• MDR Text Key: 126113476
• Report Number: 1000113657-2018-01080
• 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: Replace
• Type of Report: Initial
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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