MAUDE Adverse Event Report: TRIVIDIA HEALTH INC SYRINGES; PISTON SYRINGE

Model Number	SYR, NPD 1.0CC 29G 100CT1/2" 8/CS
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes.Complaint was initially reported via e-mail and customer was contacted by telephone.Per the customer the box the syringes were delivered in had been damaged; customer stated the box of syringes was not inside the other packaging and the syringes had been exposed.Customer stated that she was not comfortable using the syringes in that condition.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were not returned for evaluation.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: SYRINGES
• Common Device Name: PISTON SYRINGE
• 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: 23921433
• Report Number: 1000113657-2025-00481
• Device Sequence Number: 21092684
• Product Code: FMF
• UDI-Device Identifier: 00021292005825
• UDI-Public: (01)00021292005825(17)300518(10)NP25139
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K993017
• 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): 12/30/2025

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: SYR, NPD 1.0CC 29G 100CT1/2" 8/CS
• Device Lot Number: NP25139
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/08/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/30/2025
• 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