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

Model Number SYR, NPD 0.3CC 29G 100CT1/2" 8/CS

Device Problem Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Products were not returned for evaluation - customer discarded defective products.Note: manufacturer contacted customer in follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for syringe needle to be out of protective cover.The customer did not report symptoms.Customer states she has 4 other boxes that are unopened.Customer opened one box while on the phone, but could not find any uncapped syringes in the other box.Customer states she is unable to go through all the needles at the time of the call but will call if any concerns arise.Medical attention was not reported as a result of the exposed needle.The product storage location was undisclosed.The syringes lot manufacturer¿s expiration date is 01/28/2023 and open date is (b)(6) 2020.

Manufacturer Narrative

Sections with additional information as of 08-mar-2021.H6: updated investigation conclusion: most likely underline root cause: mlc-063 damaged during transit.

• Brand Name: SYRINGES
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10996777
• MDR Text Key: 229565518
• Report Number: 1000113657-2020-00892
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2023
• Device Model Number: SYR, NPD 0.3CC 29G 100CT1/2" 8/CS
• Device Lot Number: NP20030
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/16/2020
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1