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

Model Number	PNDL, 3BV TVH TP 31G 8MMTC 100CT 30/CS BLUE
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Skin Tears (2516)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were returned for evaluation.Evaluation in process.Manufacturer contacted customer in a follow-up call on 28-apr-2025 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated that he only used one of the replacement pen needles and will continue to use more to see if the issue happens again.
Event or Problem Description
Consumer reported complaint for the trueplus pen needles.Customer stated that the 31g pen needles are bending when he inserts them and they are not aspirating the insulin.Customer is feeling well at this time and is not having any diabetic symptoms.Customer also advised that in the area in which he administers his insulin, when he is removing the needle, it somewhat "tears the skin and leaves a black and blue mark".No medical intervention associated with the use of the product was reported.The package had not been open or damaged when received by the customer.Customer does not recall how long he has been using the product out of this package.The customer is using compatible product and the pen needle is properly aligned.
Additional Manufacturer Narrative
Sections with additional information as of 21-jul-2025: h3: was the device evaluated by the manufacturer and if the device was not evaluated, select from the approved fda codes or select 'other' and enter text in h10.H6: updated fda¿s type, findings and conclusions codes.H10: pen needles were returned ; unable to ship returned product to the manufacturer due to biohazard.Returned product scrapped.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer using pen needles from the same lot.No abnormalities observed with retention samples.Most likely underlying root cause: mlc-009: use error caused or contributed to event.

• 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: 21994101
• Report Number: 1000113657-2025-00163
• Device Sequence Number: 4263555
• Product Code: FMI
• UDI-Device Identifier: 00021292012809
• UDI-Public: (01)00021292012809(17)261130(10)1L605
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 07/21/2025

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, 3BV TVH TP 31G 8MMTC 100CT 30/CS BLUE
• Device Lot Number: 1L605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/17/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/21/2025
• 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