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

Model Number	LCT, TP NPD 33G 100CT 50/CASE MULTICOLOR
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus 33g lancets.Customer stated that the tip on some of the needles is bent.Customer stated the package had not been open or damaged when received.The customer has been using the product out of this package for one month.At the time of the call the customer felt well and did not report any symptoms.Customer did not claim they were injured while using the lancets and no medical intervention related to the use of the product was reported.No further information was provided.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Lancets were returned for evaluation.Evaluation in process.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Additional Manufacturer Narrative
Sections with additional information as of 02-aug-2022: h3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: returned product was forwarded to supplier quality to contact the manufacturer.Manufacturer's investigation has been completed and root cause selected.Defect found on returned lancet; bent needles.No abnormalities observed with retention samples.Root cause: rc-078: improperly shipped.

• 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: 14674694
• Report Number: 1000113657-2022-00335
• Device Sequence Number: 11985784
• Product Code: FMK
• UDI-Device Identifier: 00021292004484
• UDI-Public: 021292004484
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/02/2022

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 NPD 33G 100CT 50/CASE MULTICOLOR
• Device Lot Number: 210708NM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/16/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 08/02/2022
• 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