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

Model Number	PNDL, 3BV TVH TP 32G 4MMTC 100CT 30/CS YELLOW
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were returned for evaluation.Reported defect not reproduced.No defect found.Most likely underline root cause - mlc-061 improper use/mishandle by end user note: manufacturer attempted to contact customer on several occasions to ensure the customer's initial concern was resolved-unable to establish contact with customer.
Event or Problem Description
Consumer reported complaint of inaccurate dispense of the pen needles stating that some did not inject her insulin.Customer has been using the product for about one month.Customer stated the package had not been open or damaged when received.Customer is using compatible product (humalog qwik pen) and the pen needle is properly aligned.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.The pen needle lot manufacturer¿s expiration date is 01/31/2025 and open vial date is approximately one month ago.

• 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
• MDR Report Key: 11613783
• Report Number: 1000113657-2021-00229
• Device Sequence Number: 3127756
• Product Code: FMI
• UDI-Device Identifier: 00021292012816
• UDI-Public: (01)00021292012816
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/05/2021

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: 0B609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Distributor Facility Aware Date: 03/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1