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

Model Number	PNDL, 3BV TVH TP 31G 6MMTC 100CT 30/CS PURPLE
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
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 several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint that the 31g pen needles were dull and not sharp.Customer has been using the product for a few weeks.Customer stated that some of the pen needles are not sharp enough causing her to have to use another.Customer stated the package had not been open or damaged when received.Customer is using compatible product and the pen needle is properly aligned.The customer keeps her skin taut when injecting into her skin.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.

• 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: 11466393
• Report Number: 1000113657-2021-00170
• Device Sequence Number: 11748673
• Product Code: FMI
• UDI-Device Identifier: 00021292012793
• UDI-Public: (01)00021292012793
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/11/2021

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: 02/28/2025
• Device Model Number: PNDL, 3BV TVH TP 31G 6MMTC 100CT 30/CS PURPLE
• Device Catalogue Number: S5H01C31-100TC
• Device Lot Number: 0C620
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/11/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1