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

Model Number	LCT, TP GNP 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	01/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Lancets were returned - product evaluation in-process.Note: manufacturer contacted customer in a follow-up call on 01-feb-2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Event or Problem Description
Consumer reported complaint for the trueplus 33g lancets.Customer stated that both the lancets and the lancet needles were bent.The package had not been open or damaged when received by the customer.The customer has been using the lancets out of this package for one month.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 18-may-2022: h3: was the device evaluated by the manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: lancets were returned for evaluation.Lancets were forwarded to supplier quality to contact the manufacturer.Internal evaluation was performed by the manufacturer and defect found: bent lancet.The manufacturer issued a capa and scar 22-004 was assigned per thi qa supplier.No abnormalities found in device history record.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: 13558530
• Report Number: 1000113657-2022-00088
• Device Sequence Number: 17256456
• Product Code: FMK
• UDI-Device Identifier: 00087701426063
• UDI-Public: 087701426063
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 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: 01/21/2026
• Device Model Number: LCT, TP GNP 33G 100CT50/CASE MULTICOLOR
• Device Lot Number: 210118NM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/24/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 02/18/2022
• 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