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	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes 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 syringes from the same lot.No abnormalities observed with retention samples.Most likely underlying root cause: mlc-009: use error caused or contributed to event.Note: manufacturer contacted customer in a follow-up call on 04-aug-2025 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes.Customer stated that one of the 31g syringes did not have the protective cap on the syringe and the needle was exposed.Customer stated that the cap was not in the box of syringes.At the time of the call the customer felt well and did not report any symptoms customer stated she was not stuck with the needle and no adverse event was reported with the use of the product.The package was not open or damaged when received by the customer.The customer has been using the product since (b)(6) 2025.

• 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: 22793224
• Report Number: 1000113657-2025-00265
• Device Sequence Number: 12920163
• Product Code: FMF
• UDI-Device Identifier: 00021292005870
• UDI-Public: (01)00021292005870(17)290602(10)NP24112
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 08/13/2025

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: NP24112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Distributor Facility Aware Date: 07/17/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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