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

Model Number	PNDL, 5BV TVH TP 31G 6MM 100CT 30/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus pen needles.Consumer reported complaint for inaccurate dispense/aspiration of the 31g pen needles stating that he had used 20 of the pen needles and that 10 had been "clogged." the package was not open or damaged when received by the customer.This is not the first time the customer is using the product out of this package; customer could not confirm exactly how long he has been using the product.The customer is using compatible product and the pen needle is properly aligned.At the time of the call the customer felt well and did not report any symptoms.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
Internal report reference number: (b)(4).Pen needles were returned - product evaluation in-process.Note: manufacturer contacted customer in a follow-up call on 07-oct-2024 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated he had not yet received the replacement products; product was to be re-shipped to the customer.
Additional Manufacturer Narrative
Sections with additional information as of 21-mar-2025: h3: was the device evaluated by the manufacturer and if the device was not evaluated, select from the approved fda codes or select 'other' and enter text in h10.H6: updated fda¿s type, findings and conclusions codes.H10: pen needles were returned - unable to ship returned product to manufacturer due to biohazard.Return product scrapped.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer using pen needles from the same lot.No abnormalities observed with retention samples.Most likely underlying root cause: mlc-009: use error caused or contributed to event.Note: replacement product had been re-shipped to customer.Manufacturer contacted customer in a follow-up call on 07-oct-2024 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern and that they are using the pen needles.

• 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: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 20470607
• Report Number: 1000113657-2024-00409
• Device Sequence Number: 20733841
• Product Code: FMI
• UDI-Device Identifier: 00021292010782
• UDI-Public: (01)00021292010782(17)270930(10)2J611
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K180720
• 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): 03/21/2025

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 Model Number: PNDL, 5BV TVH TP 31G 6MM 100CT 30/CS
• Device Lot Number: 2J611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/24/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 03/21/2025
• 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