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

Model Number	SYR, NPD 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	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: 64522-1 syringes were not returned for evaluation.Note: manufacturer contacted customer within several follow-up emails to ensure the initial concern is resolved - unable to establish contact with customer at this time.
Event or Problem Description
Manufacturer received complaint via e-mail.Consumer reported complaint for the syringes (no aspiration).Customer had purchased a box of single-use syringes about a month ago.Since then a few of the syringes malfunctioned while attempting to fill them with insulin.The customer did not report symptoms or medical attention.The product storage location is undisclosed.The test strip lot manufacturer¿s expiration date is 01/12/2023.

• 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: 11028523
• Report Number: 1000113657-2020-00907
• Device Sequence Number: 19005406
• Product Code: FMF
• UDI-Device Identifier: 00021292005863
• UDI-Public: (01)00021292005863
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 12/17/2020

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: 01/12/2023
• Device Model Number: SYR, NPD 0.3CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP20007
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1