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

Model Number	PNDL, 5BV TVH TP 31G 8MM100CT 30/CS
Medical Device Problem Codes	Material Twisted/Bent (2981); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the trueplus pen needles.Customer stated that the pen needles are not dispensing the insulin or they are bent.Customer stated that she had 2 other boxes and a few of them had the same issue; customer stated she had discarded the boxes (100 pen needles each one).The package had not been open or damaged when received by the customer.Customer has been using the pen needles out of this package for a few days.The customer is using compatible product and the pen needle is aligned properly.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).Additional report reference numbers: (b)(4).Pen needles were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 03-jan-2024 to ensure the replacement products resolved the initial concern, customer stated they are comfortable with the replacement products.
Additional Manufacturer Narrative
Sections with additional information as of 26-feb-2024: h10: pen needles were returned - received 23 exposed pen needles without the protective cover and cover cap; unable to ship to the manufacturer due to needle exposed.Return product was scrapped.
Additional Manufacturer Narrative
Sections with additional information as of 18-apr-2024: h6: updated fda¿s type, findings and conclusions codes.H10: complaint was forwarded to supplier quality based on complaint's description for investigations.Customer returned 23 exposed pen needles without the protective cover and cover cap; unable to ship to the manufacturer due to needle exposed.Scrap returned product.Internal evaluation has been completed by the manufacturer.No abnormalities observed with retention samples.Most likely underlying root cause: mlc-009: use error caused or contributed to event.

• 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: 18494276
• Report Number: 1000113657-2024-00014
• Device Sequence Number: 20597057
• Product Code: FMI
• UDI-Device Identifier: 00021292010799
• UDI-Public: (01)00021292010799
• 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,Followup
• Report Date (Section B): 04/18/2024

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 31G 8MM100CT 30/CS
• Device Lot Number: 2H614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/15/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 02/01/2024; 03/25/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/26/2024; 04/18/2024
• 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