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

Model Number	PNDL, 5BV TVH TP 32G 4MM100CT 30/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus pen needles.Consumer reported complaint the 32g pen needles are not dispensing her insulin.Customer stated the package had not been open or damaged when received.Customer is using 2 different insulin pens, and both are compatible with the true plus pen needles.Customer advised that she has had about 5 of the pen needles form the box that did not work.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 for evaluation.Evaluation in process.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.
Additional Manufacturer Narrative
Sections with additional information as of 03-oct-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 - unable to ship returned product to the 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: follow-up call to customer completed: manufacturer contacted customer in a follow-up call on 15-jul-2024 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

• 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: 19741553
• Report Number: 1000113657-2024-00288
• Device Sequence Number: 17036271
• Product Code: FMI
• UDI-Device Identifier: 00021292010805
• UDI-Public: (01)00021292010805(17)270
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/03/2024

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 32G 4MM100CT 30/CS
• Device Lot Number: 2I614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2024
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/18/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 10/03/2024
• 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