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

Model Number LCT, TP GNP 30G 100CT50/CASE DK BL

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lancets were returned for evaluation.Investigation in process.Note: manufacturer contacted customer in a follow-up call on 05-oct-2021 to ensure the replacement products resolved the initial concern-able to establish contact with customer.Customer doesn¿t have the new product with him but he stated that he is not having issues with the new box of lancets but he also stated that even tough we recommended him to cease the use of the lancets that he alleged were defective he was using more lancets from that lot # and they were working fine and he will send us back the lancets that he found with the issue (needle came out with the protective cap) and the lancets that he has left in that box.

Event Description

Consumer reported complaint for the 30g lancets.Customer stated the needle came off when he twisted and removed the protective cap.Customer stated he had tried two more lancets from the same box and the needle had come off as well.The package had not been open or damaged when received by the customer.This was the first time the customer had used the product out of this package.The customer feels well and did not report any symptoms.The customer did not claim they were injured while using the lancets and no medical attention associated with the use of the product was reported.

Manufacturer Narrative

Sections with additional information as of 23-nov-2021: 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 visually inspected: needle did not come out upon removal of lancet cap, no defect found.Returned product was forwarded to supplier quality to contact manufacturer.Manufacturer investigation completed and no abnormalities observed on returned product, retain samples, and review batch record.Most likely underlying root cause: mlc-061: improper use/mishandle by end user.

• Brand Name: LANCET-100
• Type of Device: 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: 12685741
• MDR Text Key: 282224705
• Report Number: 1000113657-2021-00666
• Device Sequence Number: 1
• Product Code: FMK
• UDI-Device Identifier: 00087701426056
• UDI-Public: 087701426056
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: LCT, TP GNP 30G 100CT50/CASE DK BL
• Device Lot Number: 201039NM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/24/2021
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 11/02/2021
• Supplement Dates FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1