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	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were returned for evaluation- evaluation in process.Note: manufacturer contacted customer in a follow-up call on 10-jul-2024 to ensure the replacement products resolved the initial concern -able to establish contact with customer who stated they are comfortable with the new replacement products.
Event or Problem Description
Pharmacist reported complaint for the trueplus pen needles.Caller stated that one of the pen needles in the box has some "fuzzy black stuff" under the cap of one of the pen needles and the needle is sealed under the plastic wrapper.Caller stated that the product was opened about 1 week ago and it was located in the bottom of the box.Caller advised that box was sealed and intact upon receipt.No symptoms or medical attention associated with the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 08-sep-2025: h3: was the device evaluated by the manufacturer? h6: updated fda¿s type, findings and conclusions codes.H10: complaint was forwarded to supplier quality and defect found on returned pen needle: supplier manufacturing defect due to foreign matter observed.The reported defect is confirmed.Internal evaluation was performed by the manufacturer using pen needles from the same lot.No abnormalities observed with retention samples.Root cause: rc-075: supplier manufacturing defect.

• 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: 22473136
• Report Number: 1000113657-2025-00237
• Device Sequence Number: 14521064
• Product Code: FMI
• UDI-Device Identifier: 00021292010805
• UDI-Public: (01)00021292010805(17)291031(10)4K607
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Pharmacist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: Health Professional
• Device Model Number: PNDL, 5BV TVH TP 32G 4MM100CT 30/CS
• Device Lot Number: 4K607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/16/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 09/08/2025
• 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