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

Model Number	LCT, TP NPD 30G 100CT50/CASE DK BL
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus lancets.Daughter is calling on behalf of the customer.Per caller the needle is bent when she takes the protective covering off.The package was not open or damaged when received by the customer.The customer feels well and did not report any symptoms.The customer is not claiming to have been injured using the lancets.No medical attention associated with the use of the product was reported.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Lancets were not returned for evaluation.Complaint was forwarded to supplier quality based on complaint's description for investigations.No product was returned to thi.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 several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

• 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: 25045456
• Report Number: 1000113657-2026-00183
• Device Sequence Number: 9726241
• Product Code: QRK
• UDI-Device Identifier: 00021292004460
• UDI-Public: (01)00021292004460(17)290719(10)240711NM
• Combination Product (Y/N): N
• PMA/510(K) Number: K220475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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 30G 100CT50/CASE DK BL
• Device Lot Number: 240711NM
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/03/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/30/2026
• 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