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	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).8 syringes were returned for evaluation.Evaluation in process most likely underlying root cause: mlc-009: use error caused or contributed to event.Note: manufacturer contacted customer in a follow-up call 17-jun-2024 to ensure the customer¿s initial concern was resolved- the customer stated that she is satisfied with replacement.
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes, stating that the syringe would not draw in medication.Customer is not a diabetic but uses the syringes for her injectable migraine medication.Customer was advised that the true plus syringes are designed for insulin use only.The package was not open or damaged when received.The customer has been using the product for about 1 month.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.

• 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: 19671127
• Report Number: 1000113657-2024-00280
• Device Sequence Number: 3115792
• Product Code: FMF
• UDI-Device Identifier: 00021292005825
• UDI-Public: (01)00021292005825(17)280
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/03/2024

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: NP23053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2024
• Distributor Facility Aware Date: 06/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 07/03/2024
• 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