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

Model Number NDL, PEN LDR TP 31G 5MM100CT 30/CS

Device Problem No Flow (2991)

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

Event Date 04/01/2024

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Syringes were not returned for evaluation.Note: manufacturer contacted customer in several 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 the trueplus single-use insulin syringes; complaint was reported via e-mail.Customer reported complaint for inaccurate dispense for the 31g syringes.Customer stated that the insulin aspirated correctly but did not dispense from the syringe; customer stated that the needle tip seemed "clogged." customer stated that she had broken some of the plungers attempting to dispense the insulin.Customer stated it was occurring in about one out of three syringes.Customer brought the syringes to the pharmacy where she had purchased them, and they also had been unable to dispense the insulin from the syringes.Pharmacy had advised customer to contact manufacturer.Manufacturer was able to contact the customer via telephone; customer stated she was unable to troubleshoot at the time and would contact manufacturer either by phone or e-mail when available.No symptoms or medical attention associated with the use of the product were reported.Lot information for the syringes was not provided.

• 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: 19153467
• MDR Text Key: 341597289
• Report Number: 1000113657-2024-00172
• 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
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NDL, PEN LDR TP 31G 5MM100CT 30/CS
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/01/2024
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/22/2024
• 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