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

Model Number SYR, GNP 1.0CC 30G 100CT5/16" 8/CS

Device Problem Contamination (1120)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Syringes were returned - customer had returned used syringes, unable to be shipped to the manufacturer.Returned product scrapped.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.Note: manufacturer contacted customer in a follow-up call on 20-feb-2024 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

Event Description

Consumer reported complaint for the trueplus single-use insulin syringes.Customer stated that when he opened the "bag" the syringes were dispensed in, there was something on the product that looks like blood/heroine.Customer stated that he picked up the rx from the pharmacy yesterday, and the rx came in a bag, and he was dispensed 10 syringes.The syringes were not in a thi box, however the labeling on the rx bag had the lot number that the syringes came from.Customer stated he did not use any of the syringes from the bag.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.

• 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: 18818048
• MDR Text Key: 336679629
• Report Number: 1000113657-2024-00094
• 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: Replace
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SYR, GNP 1.0CC 30G 100CT5/16" 8/CS
• Device Lot Number: NP22306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Distributor Facility Aware Date: 02/07/2024
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• 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