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

Model Number	SYR, KGR 0.3CC 31G 100CT 5/16 8/CS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Supplemental report will be sent after pending investigation of returned products.
Event or Problem Description
Consumer reported complaint for syringe needles breaking while withdrawing insulin.The expected fasting blood glucose test result range is undisclosed.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.The syringe needle lot manufacturer¿s expiration date is feb 25, 2021 and open vial date is undisclosed.
Additional Manufacturer Narrative
Sections with additional information as of 28-feb-2020: h6: updated fda's method, result, and conclusion codes h10: syringes were returned for evaluation.No defect was detected.H10: 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 customer's products resolved the initial concern - unable to establish contact with customer at this time.Product notification letter sent to contact customer care.

• Brand Name: SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 9703254
• Report Number: 1000113657-2020-00077
• Device Sequence Number: 1681167
• Product Code: FMF
• UDI-Device Identifier: 00041260385100
• UDI-Public: (01)00041260385100
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/28/2020

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: 02/25/2021
• Device Model Number: SYR, KGR 0.3CC 31G 100CT 5/16 8/CS
• Device Lot Number: NP18019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Distributor Facility Aware Date: 01/15/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1