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

Model Number	PNDL, 3BV TVH TP 32G 4MMTC 100CT 30/CS YELLOW
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/02/2020
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 15-dec-2020 to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern, customer states he just wanted to report the defective pen needles.
Event or Problem Description
Consumer reported complaint for the pen needles.Husband is calling on behalf of the customer.The customer feels well and did not report any symptoms.The customer did not need any medical intervention related to the use of the product.The package was not open or damaged when received.Customer has been using these pen needles for several weeks, using with compatible products and the pen needles were properly aligned.Customer was concerned the product was unable to administer wife's insulin or inaccurate dispense her insulin.
Additional Manufacturer Narrative
Sections with additional information as of 11-feb-2021: d10: device available for evaluation.H3: device evaluated by manufacturer.H6: updated fda's method, result, and conclusion codes.H10: pen needles were returned for evaluation.Defect was detected.Pen needles arrived without protective seal and with inner component bent: can not align or dispense properly.Root cause: rc-076: mishandled by the end user.

• Brand Name: PEN NEEDLES
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 11085138
• Report Number: 1000113657-2020-00925
• Device Sequence Number: 11652974
• Product Code: FMI
• UDI-Device Identifier: 00021292012816
• UDI-Public: (01)00021292012816
• 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,other
• Initial Reporter Occupation: Other
• Remedial Action: Other,Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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 Expiration Date: 01/31/2025
• Device Model Number: PNDL, 3BV TVH TP 32G 4MMTC 100CT 30/CS YELLOW
• Device Catalogue Number: S5H01A32-100TC
• Device Lot Number: 0B620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Distributor Facility Aware Date: 12/02/2020
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1