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

Model Number	LCT, TP LDR 33G 100CT50/CASE MULTICOLOR
Medical Device Problem Codes	Product Quality Problem (1506); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Consumer reported complaint for the 33g multi-color trueplus lancets.Customer stated that part of the cap stayed on the surface of the needle after she had removed it; customer stated it was "a piece of plastic chunk." customer is using the product out of this package for the first time and stated that all of the lancets she has used so far have had the same issue.Customer stated that she is not able to lance her finger and she is not able to obtain a blood sample using the lancets.Customer stated the package had not been open or damaged when received.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 12-jul-2022: h6: updated fda¿s type, findings and conclusions codes.H10: 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-009: use error caused or contributed to event.

• 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: 14621027
• Report Number: 1000113657-2022-00319
• Device Sequence Number: 5936020
• Product Code: FMK
• UDI-Device Identifier: 00096295125665
• UDI-Public: 096295125665
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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: 07/27/2026
• Device Model Number: LCT, TP LDR 33G 100CT50/CASE MULTICOLOR
• Device Lot Number: 210701NM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/11/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/12/2022
• 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