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 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-140- supplier manufacturing defect.Based on the post market review syr-pmr-100 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 in a follow-up call to ensure that the initial concern was resolved - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.

Event Description

Customer is calling stating that every time he buys a box of our syringes, they do not aspirate fluid correctly.Customer states that there is too much air in the syringes.I verified that customer is tilting back insulin vial to where its upside down and needle is facing up.Customer stated that the needle is always submerged in fluid therefore there should be fluid being sucked into the syringe.Customer states that he has bought 7 100 ct boxes separately and that it constantly happens.I apologized for the inconvenience.Customer has only four syringes left.Bag lot number is np16005.Customer will be sending us those unused syringes back for investigation.I will send a 100 count box of syringes and 100 ct vial of strips for customer satisfaction.

• 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: 7973777
• MDR Text Key: 124672661
• Report Number: 1000113657-2018-01053
• 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: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: NP16005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/17/2018
• 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