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

Model Number	PNDL, 5BV TVH TP 31G 8MM100CT 30/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2024 to ensure that the initial concern was resolved - able to establish contact with customer who stated the initial issue has been resolved.The customer is waiting to get compatible needles for her tresiba insulin pen.
Event or Problem Description
Consumer reported complaint for the trueplus pen needles.Customer has been using the product for a few days.The package was not open or damaged when received by the customer.Customer is using a tresiba pen that is not compatible with the trueplus pen needles.Customer is also using the novolog flex pen and customer was advised that it is compatible with the trueplus pen needles.Customer stated she will let her pharmacist know.At the time of the call the customer felt well and did not report any symptoms.No medical intervention related to the use of the product was reported.The lot expiration date is 07/31/2027 and the open date was a few dates prior to the call.

• 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: 19096268
• Report Number: 1000113657-2024-00155
• Device Sequence Number: 20798045
• Product Code: FMI
• UDI-Device Identifier: 00021292010799
• UDI-Public: (01)00021292010799
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

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 8MM100CT 30/CS
• Device Lot Number: 2H629
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/21/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 04/12/2024
• 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