MAUDE Adverse Event Report: TRIVIDIA HEALTH INC PEN NEEDLES FG; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	PNDL, 5BV TVH TP 31G 5MM100CT 30/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).15 pen needles were returned.Evaluation in process.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure the customer¿s initial concern has been resolved- able to establish contact with customer who stated they are comfortable with the pen needles from the new box.
Event or Problem Description
Consumer reported complaint for inaccurate dispense of true plus pen needles.The expected fasting blood glucose test result range is undisclosed.Customer states that his glucose numbers went up high and he is not sure why.Customer states that the only thing that change was the new pen needles he is using.Customer believes the box of pen needles that he opens up was not giving him enough insulin and that cause his blood sugar to go up higher.The customer did not report symptoms.Medical attention is not reported as a result of inaccurate dispense of pen needles.The product storage location is undisclosed.During the call a blood test was not performed by the customer.Customer states that he opens up a new box of pen needles and everything is back to normal his blood sugar is back to normal.The test strip lot manufacturer¿s expiration date is 03/31/2026 and open vial date is 1 week ago.
Additional Manufacturer Narrative
Sections with additional information as of 20-jan-2023: h3: was the device evaluated by the manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: pen needles were returned for evaluation.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer.No abnormalities observed with returned and retention samples.Most likely underlying root cause: mlc-009: use error caused or contributed to event.

• Brand Name: PEN NEEDLES FG
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: 15982680
• Report Number: 1000113657-2022-00653
• Device Sequence Number: 6209127
• Product Code: FMI
• UDI-Device Identifier: 00021292010775
• UDI-Public: (01)00021292010775
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2026
• Device Model Number: PNDL, 5BV TVH TP 31G 5MM100CT 30/CS
• Device Catalogue Number: S5H01B(31)-100
• Device Lot Number: 1D609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/21/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown