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

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

Device Problems Product Quality Problem (1506); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2023

Event Type  malfunction  

Event Description

Consumer reported complaint for the trueplus single-use insulin syringes, stating the 31g syringes leaked and did not accurately dispense the insulin.Customer also stated that the plunger is loose.The package not been open or damaged when received by the customer.The customer's syringes are expired: manufacturer's expiration date is 05/28/2022.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.Customer declined replacement, stating she just wanted to report the issue.

Manufacturer Narrative

Internal report reference number: (b)(4).Syringes were not returned for evaluation.Most likely underlying root cause: mlc-012: product expired.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2023 to ensure that the initial concern was resolved - able to establish contact with customer who stated the syringes are working as intended and she has not experienced any more issues.Customer was aware the syringes were expired and stated she would order new syringes.

• Brand Name: SYRINGES
• 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: 17105730
• MDR Text Key: 316976504
• Report Number: 1000113657-2023-00318
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 000212920058
• UDI-Public: (01)000212920058
• 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: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2022
• Device Model Number: SYR, NPD 1.0CC 31G 100CT5/16" 8/CS
• Device Lot Number: NP19133
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/17/2023
• Date Manufacturer Received: 05/17/2023
• 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