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

Model Number	PNDL, 5BV WGN 31G 5MM 50CT 60/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus pen needles.Per customer the pen needles did not dispense the insulin.Customer stated she had contacted the pharmacy on the day of the call for assistance and had been advised to contact the manufacturer.Per customer the package had not been open or damaged when received and had been opened on the day of the call.The customer is using compatible product and the pen needle is properly aligned.Customer reported feeling dizzy; medical attention was not needed at the time of the call.Customer did not claim to be injured while using the pen needles and no medical intervention related to the use of the product was reported.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B2: adverse event report is being submitted due to customer contacting pharmacy for assistance due to inaccurate dispense of pen needles.Pen needles were not returned for evaluation.Note 1: manufacturer contacted customer in a follow-up call on 02-mar-2026 to ensure the customer's condition had improved and the replacement products resolved the initial concern - able to establish contact with customer who stated her condition had improved and she did not currently have any diabetic symptoms.No medical intervention since the last call was reported.Customer stated the replacement products resolved the initial concern.

• 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: 24569447
• Report Number: 1000113657-2026-00104
• Device Sequence Number: 8569330
• Product Code: FMI
• UDI-Device Identifier: 00311917136332
• UDI-Public: (01)00311917136332(17)291130(10)4L612
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PNDL, 5BV WGN 31G 5MM 50CT 60/CS
• Device Lot Number: 4L612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 05/20/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown