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

Model Number	PNDL, 5BV TVH TP 31G 5MM100CT 30/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Products were returned and pending qc evaluation.Most likely underlying root cause: mlc-61: improper use / mishandled by end user.Note: manufacturer contacted customer in a follow-up call on 02-jul-2020 to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.
Event or Problem Description
Consumer reported complaint for pen needles not accurately dispensing insulin.The expected fasting blood glucose test result range is undisclosed.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.The pen needle lot manufacturer¿s expiration date is 04/30/2023 and open vial date is a few weeks ago.
Additional Manufacturer Narrative
Sections with additional information as of 18-sep-2020: pen needles were returned for evaluation; visually inspected returned pen needles (5): when needle aligns and dispenses with lab prefilled insulin pens, droplets observed.Returned product was forwarded to supplier quality to contact the manufacturer.Manufacturer's investigation has been completed and root cause selected.No abnormalities observed.Most likely underlying root cause: (b)(4): user error caused or contributed to event.

• Brand Name: PEN NEEDLES
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10301715
• Report Number: 1000113657-2020-00496
• Device Sequence Number: 515549
• Product Code: FMI
• UDI-Device Identifier: 00021292010775
• UDI-Public: (01)00021292010775
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 09/18/2020

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: 04/30/2023
• Device Model Number: PNDL, 5BV TVH TP 31G 5MM100CT 30/CS
• Device Catalogue Number: S6H01B31-100
• Device Lot Number: 8E618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Distributor Facility Aware Date: 06/23/2020
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1