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	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for inaccurate dispense of the trueplus pen needles.Consumer reported complaint the 31g pen needles did not dispense the insulin; customer stated the issue had occurred with multiple pen needles.The package had not been open or damaged when received by the customer.The customer has been using the product for one month.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 - 15 used pen needles were received without the protective cover and cover cap; unable to ship to the manufacturer due to needle exposed.Return product scrapped.Note 1: manufacturer contacted customer in a follow-up call on 14-mar-2024 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated he did not receive replacement products; customer stated only the return label had been sent.New replacement product shipped to customer.Note 2: manufacturer contacted customer in a follow-up call on 20-mar-2024 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated he was awaiting receipt of the replacement products.Note 3: manufacturer contacted customer in a follow-up call on 25-mar-2024 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Additional Manufacturer Narrative
Sections with additional information as of 13-may-2024: h6: updated fda¿s type, findings and conclusions codes.H10: pen needles were returned - 15 used pen needles were received without the protective cover and cover cap; unable to ship to the manufacturer due to needle exposed.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.

• 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: 18973457
• Report Number: 1000113657-2024-00126
• Device Sequence Number: 15113004
• Product Code: FMI
• UDI-Device Identifier: 00021292010799
• UDI-Public: (01)00021292010799
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/13/2024

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: 2G607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/27/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 05/13/2024
• 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