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	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4) syringes were returned - product evaluation in-process.Note 1: manufacturer contacted customer in a follow-up call on 28-aug-2024 to ensure the replacement product resolved the initial concern - able to establish contact with customer who stated they have not yet used the replacement product.Note 2: manufacturer contacted customer in a follow-up call on 30-aug-2024 to ensure the replacement products resolved the initial concern -able to establish contact with caregiver who states she received the replacement today, but customer has not tried them as yet.She will let us know if she encounters any issues.
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes.Caregiver is calling on behalf of the customer.Caller stated that some of the syringes do not dispense the insulin.The package was not open or damaged when received by the customer.The customer has been using the product for 2 weeks.The customer feels 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 03-oct-2024: h3: device evaluated by manufacturer: no.Complaint was forwarded to supplier quality based on complaint's description for investigations.Unable to ship returned product to the manufacturer, due to biohazard.Scrap returned products.Internal evaluation has been completed by the manufacturer.No abnormalities observed with retention samples.Most likely underlying root cause: (b)(6): 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: 20191837
• Report Number: 1000113657-2024-00376
• Device Sequence Number: 7113269
• Product Code: FMF
• UDI-Device Identifier: 00021292005887
• UDI-Public: (01)00021292005887(17)281221(10)NP23187
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K993017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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 31G 100CT5/16" 8/CS
• Device Lot Number: NP23187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/19/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/03/2024
• 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