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	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were returned - product evaluation in-process.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2024 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, stating that the 29g syringes did not aspirate.Customer stated that needle seemed like it does not have a hole to pull in the medication.Customer is not a diabetic and she uses the syringes for her injectable migraine medication.The package was not open or damaged when received by the customer.The package was opened by the customer on or around (b)(6) 2024.At the time of the call the customer felt well and did not report any symptoms.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
Sections with additional information as of 22-jul-2024: g1: reporting contact first and last name updated from ¿(b)(6)¿ to ¿(b)(6)¿; reporting contact email updated from ¿(b)(6)¿ to ¿(b)(6)¿.H10: 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.

• 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: 19358186
• Report Number: 1000113657-2024-00228
• Device Sequence Number: 6367883
• Product Code: FMF
• UDI-Device Identifier: 00021292005825
• UDI-Public: (01)00021292005825
• 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,Followup
• Report Date (Section B): 07/22/2024

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: NP23173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2024
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/29/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/22/2024
• 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