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

Model Number	PNDL, 5BV TVH TP 31G 8MM100CT 30/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus pen needles.Consumer reported complaint of experiencing pain when using and inaccurate dispense for the 31g pen needles.The customer stated that he has been using this brand of pen needle for 5 years; customer stated the pen needles work as intended only 10% of the time.The package was not open or damaged when received by the customer.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.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were returned - product evaluation in-process.Most likely underlying root cause: mlc-008: failure to follow instructions.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

• 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: 21874504
• Report Number: 1000113657-2025-00140
• Device Sequence Number: 8641455
• Product Code: FMI
• UDI-Device Identifier: 00021292010799
• UDI-Public: (01)00021292010799(17)290131(10)4B610
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180720
• 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
• Report Date (Section B): 04/21/2025

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 31G 8MM100CT 30/CS
• Device Lot Number: 4B610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• Distributor Facility Aware Date: 03/27/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/21/2025
• 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