MAUDE Adverse Event Report: TRIVIDIA HEALTH INC LANCET-100; BLOOD LANCETS

Model Number	LCT, TP NPD 33G 100CT50/CASE MULTICOLOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Lancets were returned; product evaluation in-process.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern: unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for the trueplus lancets.Customer stated that after testing, she attempted to re-cap the needle but the needle broke; per the customer, she couldn't find the needles.The package had not been open or damaged when received by the customer.The customer did not mention how long she has been using the lancets.At the time of the call, the customer felt well and did not report any symptoms.Customer did not claim to be injured while using the lancets, and no medical intervention related to the use of the product was reported.

• Brand Name: LANCET-100
• Common Device Name: BLOOD LANCETS
• 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: 24479846
• Report Number: 1000113657-2026-00083
• Device Sequence Number: 13317288
• Product Code: QRK
• UDI-Device Identifier: 00021292004484
• UDI-Public: (01)00021292004484(17)300611(10)250501TR
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K220475
• 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): 05/26/2026

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: LCT, TP NPD 33G 100CT50/CASE MULTICOLOR
• Device Lot Number: 250501TR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2026
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 05/26/2026
• 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