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

Model Number SYR, NPD 1.0CC 29G 100CT1/2" 8/CS

Device Problems Obstruction of Flow (2423); Material Twisted/Bent (2981)

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

Event Date 03/06/2023

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Syringes were not returned for evaluation.Product lot number was not provided, supplier unable to investigate.Most likely underlying root cause: (b)(4): there was not enough information to determine the mlurc.Note 1: manufacturer contacted company representative in a follow-up call on (b)(6) 2023 to ensure that the initial concern was resolved - company representative stated that the customer had not yet received replacement product.Company representative stated she would contact the customer and then reply via e-mail.Note 2: manufacturer contacted company representative in follow-up call to ensure the initial concern is resolved - manufacturer was unable to establish contact at this time.

Event Description

Consumer reported complaint for the 29g trueplus single-use insulin syringes.Company representative/ distributor reported complaint on behalf of the customer via e-mail: external reference number (b)(4).Syringe lot number was not provided.Customer had reported that the syringes were bent and clogging and were unable to be used.No symptoms or medical intervention associated with the use of the product was reported.Manufacturer was unable to contact distributor via telephone; no further information was able to be obtained.

• 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: 16654826
• MDR Text Key: 312419933
• Report Number: 1000113657-2023-00172
• 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,Company Representative,Distributor
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• 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 29G 100CT1/2" 8/CS
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/07/2023
• Date Manufacturer Received: 03/07/2023
• 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