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

Model Number	SYR, NPD 0.3CC 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	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus single-use insulin syringes.Customer advised that when she goes to administer her insulin, the 31g syringe does not administer the entire dose of the insulin that had been drawn into it.The package had not been open or damaged when received by the customer.The customer has been using the product out of this package for about one month.The customer feels well and did not report any symptoms.The customer is not claiming they were injured 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 returned - product evaluation in-process.Note: customer contacted manufacturer on 02-oct-2023 - customer stated the initial issue has been resolved.Customer did not go to the pharmacy for replacement product - manufacturer had contacted the pharmacy on behalf of the customer and pharmacy will contact the customer regarding replacement product.
Additional Manufacturer Narrative
Sections with additional information as of 29-jan-2024: h3: was the device evaluated by the manufacturer; if the device was not evaluated, select from the approved fda codes or select 'other' and enter text in h10.H6: updated fda¿s type, findings and conclusions codes.H10: syringes (5) were returned - unable to ship to manufacturer due to biohazard.Scrap returned product.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: SYRINGE, PISTON
• 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: 17956423
• Report Number: 1000113657-2023-00513
• Device Sequence Number: 5119032
• Product Code: FMF
• UDI-Device Identifier: 00021292005863
• UDI-Public: (01)00021292005863
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

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 0.3CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP22297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2023
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/25/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 01/29/2024
• 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