MAUDE Adverse Event Report: TRIVIDIA HEALTH INC SYRINGES; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number SYR, NPD 1.0CC 29G 100CT1/2" 8/CS

Device Problems Filling Problem (1233); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Syringes were returned - product evaluation in-process.Customer stated he re-filled the prescription at the pharmacy and the new syringes were working fine.Note: manufacturer contacted customer in a follow-up calls to ensure the initial concern is resolved.Unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for syringes stating that the plunger on the 29g syringes did not work.Customer stated that the plunger did not work in 16 of the syringes and that he was unable to aspirate his insulin.Pharmacist is calling on behalf of the customer, had one syringe that the customer had provided only; customer had the remaining syringes.Pharmacist was unable to provide the lot number, but was able to confirm that the syringes were trueplus syringes as he had filled the customer¿s prescription.Customer stated he had thrown the box away and was unable to verify the lot number.Customer stated that due to the plunger not working, he would bend the needle and then recover it back when he disposed of them.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.

Manufacturer Narrative

Sections with additional information as of 09-feb-2021: h10: product returned for evaluation.Visually inspected returned syringes.Needles bent: unable to test if plunger aspirates/dispenses correctly.Defect found.Root cause rc-076: added: mishandled by the end user.Mechanical stress handling.

• Brand Name: SYRINGES
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 11100654
• MDR Text Key: 239794636
• Report Number: 1000113657-2020-00943
• Device Sequence Number: 1
• Product Code: NBW
• 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,health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SYR, NPD 1.0CC 29G 100CT1/2" 8/CS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Distributor Facility Aware Date: 12/09/2020
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1