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

Model Number	LCT, TP GNP 33G 100CT50/CASE MULTICOLOR
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4), lancets were returned for evaluation.Complaint was forwarded to supplier quality based on complaint's description for investigations.Customer returned lancet, unable to ship returned product to the manufacturer, due to biohazard.Scrap returned product.Internal evaluation has been completed by the manufacturer.No abnormalities observed with retention samples.Most likely underlying root cause mlc-009: use error caused or contributed to event note: manufacturer contacted customer in a follow-up call on 30-dec-2025 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Event or Problem Description
Consumer reported complaint for the trueplus lancets, stating that some of the lancets from the box he is currently using are dull.Per the customer the package had not been open or damaged when received.The customer first used the product out of this package about 2 months ago.At the time of the call the customer felt well and did not report any symptoms.The customer is not claiming they were injured using the lancets and no medical intervention related to the use of the product was reported.

• Brand Name: LANCET-100
• Common Device Name: LANCET, BLOOD
• 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: 24058992
• Report Number: 1000113657-2026-00016
• Device Sequence Number: 21187455
• Product Code: QRK
• UDI-Device Identifier: 00087701426063
• UDI-Public: (01)00087701426063(17)300318(10)250221TR
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Report Date (Section B): 01/13/2026

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 GNP 33G 100CT50/CASE MULTICOLOR
• Device Lot Number: 250221TR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Distributor Facility Aware Date: 12/22/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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