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

Model Number	SYR, LDR 1.0CC 28G 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	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sections with additional information as of 30-jan-2025: h6: updated fda's type of investigation, investigation findings, and investigation conclusions h10: customer returned (4) syringes; unable to ship to the manufacturer.Scrap returned product.Complaint was forwarded to supplier quality based on complaint's description for investigations.Internal evaluation has been completed by the manufacturer.No abnormalities observed with retention samples.Mlc-009: use error caused or contributed to event.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were not returned for evaluation.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.
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes.Customer stated that the 28g syringes did not aspirate.The package was not open or damaged when received by the customer.Customer is not using the syringes for insulin administration; customer stated he is using the syringes to administer the medication trimix for sexual dysfunction.Customer stated he has been using the syringes for 2 years.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: 20854000
• Report Number: 1000113657-2024-00481
• Device Sequence Number: 12935236
• Product Code: FMF
• UDI-Device Identifier: 00021292005795
• UDI-Public: (01)00021292005795(17)290122(10)NP24011
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 01/30/2025

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, LDR 1.0CC 28G 100CT1/2" 8/CS
• Device Lot Number: NP24011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/11/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/30/2025
• 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