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

Model Number	LCT, TP NPD 33G 100CT50/CASE MULTICOLOR
Medical Device Problem Codes	Break (1069); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus 33g lancets.Customer stated that he had just purchased a box of 100 lancets and that some are broken and others are missing the needle.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.Coordinator had initially spoken with customer and transferred customer's information to technician.Technician was unable to contact the customer via telephone, no further information was able to be obtained.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Lancets were not returned for evaluation.Manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.
Additional Manufacturer Narrative
Sections with additional information as of 18-may-2022.H6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: complaint was forwarded to supplier quality based on complaint's description for investigations.No product was returned to thi.Manufacturer's investigation has been completed.No abnormalities found in the device history record.However, the manufacturer issued a capa and scar 22-006 has been assigned, per thi supplier qa root cause: rc-075: supplier manufacturing defect.

• 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: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 13893146
• Report Number: 1000113657-2022-00164
• Device Sequence Number: 12246061
• Product Code: FMK
• UDI-Device Identifier: 00021292004484
• UDI-Public: 021292004484
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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 Expiration Date: 06/15/2026
• Device Model Number: LCT, TP NPD 33G 100CT50/CASE MULTICOLOR
• Device Lot Number: 210609NM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/25/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 05/19/2022
• 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