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

Model Number SYR, NPD 1.0CC 31G 100CT5/16" 8/CS

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2020

Event Type  malfunction  

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 customer's products resolved the initial concern - able to establish contact with customer and stated he did not have any syringes that had aspiration problems after initial call.

Event Description

Consumer reported complaint for syringes not aspirating.Customer stated he had two syringes in the package that he was unable to use and discarded them as a result.Customer was concerned that the product was unable to administer insulin due to not drawing.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.The syringe lot manufacturer¿s expiration date is undisclosed and open vial date is undisclosed.

• Brand Name: SYRINGE
• Type of Device: PISTON SYRINGE
• 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: 10153622
• MDR Text Key: 219004971
• Report Number: 1000113657-2020-00396
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SYR, NPD 1.0CC 31G 100CT5/16" 8/CS
• Device Catalogue Number: S4H01C31-100
• Device Lot Number: NP19197
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/18/2020
• Date Manufacturer Received: 05/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1