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

Model Number	SYR, NPD 1.0CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes, stating that the 31g syringes did not dispense the insulin.Customer stated the syringes are able to aspirate the insulin but that he is not able to inject it.The package had not been open or damaged when received by the customer.Customer has been using the product for the past two days.Customer stated he had been previously using the 30g syringes.Customer stated that he has not taken his insulin for a few days and so he needs the syringes to work.The customer feels well and did not report any symptoms.The customer did not claim to be injured while using the syringes and no medical intervention related to 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 a follow-up call on 22-may-2023 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved the initial concern.
Additional Manufacturer Narrative
Sections with additional information as of 07-july-2023: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: syringes were not returned for evaluation.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 most likely underlying root cause: mlc-009: use error caused or contributed to event.

• Brand Name: SYRINGES
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 17070614
• Report Number: 1000113657-2023-00311
• Device Sequence Number: 12473009
• Product Code: FMF
• UDI-Device Identifier: 00021292005887
• UDI-Public: (01)00021292005887
• 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,Followup
• Report Date (Section B): 07/07/2023

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 Expiration Date: 01/13/2025
• Device Model Number: SYR, NPD 1.0CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP22030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/12/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/07/2023
• 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