MAUDE Adverse Event Report: TRIVIDIA HEALTH INC PEN NEEDLES FG; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	PNDL, 5BV WGN 31G 8MM 50CT 60/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were not returned for evaluation.Most likely underlying root cause: mlc-009: use error caused or contributed to event.Note: manufacturer contacted customer in a follow-up call on 06-feb-2026: customer stated she purchased the correct pen needles to be used with the insulin that she is taking and is working as intended.
Event or Problem Description
Consumer reported complaint for the trueplus pen needles.Customer stated the pen needles were not dispensing the insulin.The package was not open or damaged when received by the customer.The customer is not using compatible product.At the time of the call the customer felt well and did not report any symptoms.No medical attention associated with the use of the product was reported.

• Brand Name: PEN NEEDLES FG
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 24284210
• Report Number: 1000113657-2026-00041
• Device Sequence Number: 15598334
• Product Code: FMI
• UDI-Device Identifier: 00311917136325
• UDI-Public: (01)00311917136325(17)270831(10)2I624
• Combination Product (Y/N): N
• PMA/510(K) Number: K180720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: PNDL, 5BV WGN 31G 8MM 50CT 60/CS
• Device Lot Number: 2I624
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown