MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE PLUS LANCETS; LANCET, BLOOD

Model Number	LCT, TP NPD 28G 100CT50/CASE LT BL
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Lancets were not returned for evaluation - customer returned empty box/carton.Note: manufacturer contacted customer in a follow-up call on 12-apr-2021 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 28g lancets.Wife is calling on behalf of the customer.Customer stated that he experienced pain after using the lancet, and when he looked in the lancet, it had two needles (double needle).Customer stated that one of the needles was bent.The package had not been open or damaged when received by the customer.At the time of the call the customer felt well and did not report any symptoms.No medical intervention related to the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 24-june-2021: 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.Internal evaluation has been completed by the manufacturer and report attached into the case.No abnormalities observed with retain samples.Added most likely underlying root cause mlc-140: supplier manufacturing defect.

• Brand Name: TRUE PLUS LANCETS
• Common Device Name: LANCET, BLOOD
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 11740826
• Report Number: 1000113657-2021-00287
• Device Sequence Number: 14411352
• Product Code: FMK
• UDI-Device Identifier: 00021292000226
• UDI-Public: 021292000226
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 04/15/2025
• Device Model Number: LCT, TP NPD 28G 100CT50/CASE LT BL
• Device Lot Number: 200401NM
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/02/2021
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1