MAUDE Adverse Event Report: TRIVIDIA HEALTH INC PEN NEEDLES FG; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	PNDL, 5BV TVH TP 32G 4MM100CT 30/CS
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were not returned for evaluation.Most likely underlying root cause: mlc-061: improper use/mishandled by end user.Note: manufacturer was unable to perform follow-up call to customer to ensure the initial concern is resolved - customer did not provide contact information.
Event or Problem Description
Consumer reported complaint for the true plus pen needles.Brother is calling on behalf of the customer.Customer stated that the pen needles were not aspirating the insulin.The package was not open or damaged when received by the customer.The customer is using the product out of this package for the first time.The customer is not using compatible product.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.

• Brand Name: PEN NEEDLES FG
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 21118062
• Report Number: 1000113657-2025-00007
• Device Sequence Number: 18313434
• Product Code: FMI
• UDI-Device Identifier: 00021292010805
• UDI-Public: (01)00021292010805(17)290430(10)4E609
• Combination Product (Y/N): N
• PMA/510(K) Number: K180720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

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: PNDL, 5BV TVH TP 32G 4MM100CT 30/CS
• Device Lot Number: 4E609
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/17/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 01/09/2025
• 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