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

Model Number	PNDL, 3BV TVH TP 31G 6MMTC 100CT 30/CS PURPLE0/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were returned - product evaluation in-process.Manufacturer contacted customer in a follow-up call on (b)(6) 2023 to ensure and to ensure the customer¿s initial concern was resolved- customer states he is comfortable with the glucose readings from the replacement products.
Event or Problem Description
Consumer reported complaint the pen needles did not dispense his insulin.Customer stated he used 3 of the pen needles.Customer stated he has 2 boxes of 100 units, 3 bevel 0.25mm x 6mm 31g x 1/4" with the same lot number; customer stated that they are true plus pen needles.The package had not been open or damaged when received.This is the first time the customer is using the product out of this package.The customer is using compatible product and the pen needle is properly aligned.Customer did not claim to be injured while using the pen needles and no medical intervention related to the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 05-apr-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.Returned product 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: 16518924
• Report Number: 1000113657-2023-00136
• Device Sequence Number: 3290455
• Product Code: FMI
• UDI-Device Identifier: 00021292012793
• UDI-Public: (01)00021292012793
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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: 08/31/2026
• Device Model Number: PNDL, 3BV TVH TP 31G 6MMTC 100CT 30/CS PURPLE0/CS
• Device Catalogue Number: S5H01C31-100TC
• Device Lot Number: 1I618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/13/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/05/2023
• 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