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

Model Number	LCT, FNT 33G 100CT 24/CASE MULTICOLOR
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus lancets.Customer stated the lancets are bent.Customer stated she twists off the cap, and it comes off easily but notices the lancets are bent and she tries to poke and it doesn't work and has to poke several times to get blood.The package had not been open or damaged when received by the customer.The customer started using the product a week ago.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.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Lancets were not returned for evaluation.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer using lancets from the same lot.No abnormalities observed with retention samples.Most likely underlying root cause: mlc-061: improper use/mishandled by end user.Note: manufacturer made several attempts to contact customer to ensure the replacement products resolved the initial concern - unable to establish contact with customer.

• 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: 23414863
• Report Number: 1000113657-2025-00391
• Device Sequence Number: 8983493
• Product Code: QRK
• UDI-Device Identifier: 00010939958662
• UDI-Public: (01)00010939958662(17)291129(10)241024TR
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/29/2025

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, FNT 33G 100CT 24/CASE MULTICOLOR
• Device Lot Number: 241024TR
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/06/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 10/29/2025
• 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