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

Model Number	SYR, NPD 0.5CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for plunger out of protective cover for the trueplus single-use insulin syringes.The customer stated that in the last several boxes of the syringes some of the plunger caps were off.The customer stated it does not affect the needle of the syringes.Per the customer the package was not open or damaged when received.The customer has been using the product for 2 weeks.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).Additional report reference number: (b)(4).Syringes were not returned for evaluation.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer.No issue noted during packaging and manufacturing process.Most likely underlying root cause: mlc-063: damaged during transit.Note: manufacturer contacted customer in a follow-up call on 17-dec-2025, to ensure the replacement products resolved the initial concern - able to establish contact with customer who indicated replacement products resolved initial concern.

• 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: 23837290
• Report Number: 1000113657-2025-00471
• Device Sequence Number: 5068455
• Product Code: FMF
• UDI-Device Identifier: 00021292005870
• UDI-Public: (01)00021292005870(17)300316(10)NP25079
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 12/18/2025

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 0.5CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP25079
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/24/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/18/2025
• 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