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

Model Number	PNDL, 5BV TVH TP 32G 4MM100CT 30/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus pen needles.Customer stated the pen needles are not dispensing her insulin.Customer has 2 boxes of the same lot number of pen needles.The package had not been open or damaged when received.Customer has been using the product for nine months.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 not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 16-feb-2024 to ensure the replacement products resolved the initial concern -able to establish contact with customer who stated they are comfortable with the replacement products.
Additional Manufacturer Narrative
Sections with additional information as of 22-apr-2024: pen needles were not returned for evaluation.:complaint was forwarded to supplier quality based on complaint's description for investigations.No product was returned to thi.Internal evaluation has been completed by the manufacturer.No abnormalities observed with retention samples.Added most likely underlying root cause onto case most likely underlying root cause: mlc-009: use error caused or contributed to event corrected sections as of: 22-apr-2024.D4: corrected lot# from 21605 to 2i605 as per manufactured report.Corrected and model number from ndl, pen ldr tp 32g 4mm100ct 30/cs to pndl, 5bv tvh tp 32g 4mm100ct 30/cs.

• 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: 18725129
• Report Number: 1000113657-2024-00070
• Device Sequence Number: 20410800
• Product Code: FMI
• UDI-Device Identifier: 00021292010805
• UDI-Public: (01)00021292010805
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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 32G 4MM100CT 30/CS
• Device Lot Number: 2I605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 04/22/2024
• 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