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

Model Number	LCT, TP LDR 33G 100CT50/CASE MULTICOLOR
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(6).Lancets were returned - product evaluation in-process.Manufacturer contacted customer in a follow-up call on (b)(6) 2023 to ensure the replacement products resolved the initial concern, able to contact customer who stated they are comfortable with the replacement products.
Event or Problem Description
Consumer reported complaint for the trueplus lancets.Customer advised that some of the lancets from the box were bent when she removed the protective covering to expose the needle.Customer advised that product was sealed and intact when she received it.The customer has been using the product out of this package since (b)(6) 2022.The customer feels well and did not report any symptoms.The customer did not claim to be injured using the lancets and no medical attention associated with the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 18-may-2023: h3: device evaluated by manufacturer.H6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: returned product was forwarded to supplier quality to contact the manufacturer.Manufacturer's investigation has been completed and root cause selected.Reported defect not reproduced.No abnormalities observed with returned samples, retention samples and batch record.Most likely underlying root cause: mlc-061: improper use/mishandled by end user.

• 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
• MDR Report Key: 16630149
• Report Number: 1000113657-2023-00168
• Device Sequence Number: 14783291
• Product Code: QRK
• UDI-Device Identifier: 00096295125665
• UDI-Public: (01)00096295125665
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Followup
• Report Date (Section B): 05/18/2023

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 LDR 33G 100CT50/CASE MULTICOLOR
• Device Catalogue Number: 4817904
• Device Lot Number: 211005NM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/01/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 05/18/2023
• 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