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

Model Number PNDL, 5BV TVH TP 32G 4MM100CT 30/CS

Device Problem Improper Flow or Infusion (2954)

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

Event Date 11/16/2023

Event Type  malfunction  

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 30-nov-2023 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

Event Description

Consumer reported complaint for the trueplus pen needles.Customer stated that the 32g pen needles did not accurately dispense the insulin.Customer stated that he is only able to dispense about 5 units of insulin the first time he attempts to inject; customer stated he has to remove the pen needle and replace with another in order to administer the remaining insulin.The package had not been open or damaged when received by the customer.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.

Manufacturer Narrative

Sections with additional information as of 29-feb-2024: 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 - customer returned pen needles without the protective cover and cover cap; unable to ship to the manufacturer due to needle exposed.Returned product scrapped.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.

• Brand Name: PEN NEEDLES FG
• Type of Device: 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: 18311782
• MDR Text Key: 330291699
• Report Number: 1000113657-2023-00606
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Public: (01)(17)270731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PNDL, 5BV TVH TP 32G 4MM100CT 30/CS
• Device Lot Number: 2H609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/16/2023
• Date Manufacturer Received: 02/08/2024
• 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