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

Model Number	SYR, KGR 0.3CC 31G 100CT5/16" 8/CS
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Syringes were not returned for evaluation.Most likely underlying root cause: mlc-61: improper use / mishandled by end user.Note: manufacturer contacted customer in a follow-up call 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 no aspiration of syringes.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product storage location is undisclosed.The syringe lot manufacturer¿s expiration date is 01/125/2021 and open vial date is undisclosed.

• Brand Name: SYRINGES
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10444470
• Report Number: 1000113657-2020-00600
• Device Sequence Number: 11755793
• Product Code: FMF
• UDI-Device Identifier: 00041260385100
• UDI-Public: (01)00041260385100
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 08/24/2020

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: 01/15/2021
• Device Model Number: SYR, KGR 0.3CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP17348
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1