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

Model Number PNDL, 5BV TVH TP 31G 8MM100CT 30/CS

Device Problems Material Twisted/Bent (2981); No Flow (2991)

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

Event Date 12/15/2023

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Additional report reference numbers: (b)(4).Pen needles were not returned for evaluation.Most likely underlying root cause: (b)(6): there was not enough information to determine the mlurc.Note: manufacturer contacted customer in a follow-up call on 03-jan-2024 to ensure the replacement products resolved the initial concern, customer stated they are comfortable with the replacement products.

Event Description

Consumer reported complaint for the trueplus pen needles.Customer stated that the pen needles are not dispensing the insulin or they are bent.Customer stated that she had 2 other boxes and a few of them had the same issue; customer stated she had discarded the other boxes (100 pen needles)-unable to provide lot numbers.The package had not been open or damaged when received by the customer.The customer is using compatible product and the pen needle is aligned properly.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.

• 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: 18494871
• MDR Text Key: 333198061
• Report Number: 1000113657-2024-00015
• Device Sequence Number: 1
• Product Code: FMI
• 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
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• 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 31G 8MM100CT 30/CS
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/15/2023
• Date Manufacturer Received: 12/15/2023
• 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