MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC PEN NEEDLES FG; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number PNDL, 3BV TVH TP 32G 4MM100CT 30/CS

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

Pen needles were not returned for evaluation.Most likely underlying root cause: mlc -61: improper use / mishandled by end user.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for pen needle inaccurate dispense/aspiration, stating that some of the pen needles are not dispensing insulin.Customer had concerns that the product is unable to administer their insulin due to the issue.The customer feels well and did not report any symptoms or that medical attention had been required.

• Brand Name: PEN NEEDLES FG
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• 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: 9120686
• MDR Text Key: 202955938
• Report Number: 1000113657-2019-10012
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00021292009076
• UDI-Public: (01)00021292009076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143437
• 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: 09/25/2019

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 Expiration Date: 10/01/2023
• Device Model Number: PNDL, 3BV TVH TP 32G 4MM100CT 30/CS
• Device Catalogue Number: S5H01A32-100
• Device Lot Number: Y58ZD4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Distributor Facility Aware Date: 08/28/2019
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1