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 Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: 158692-1.The pen needles were not returned for evaluation, complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer using pen needles from the same lot.No abnormalities observed with retention samples.30 samples were inspected, but they did not break when the pen needle was bent 90 degrees.Most likely underlying root cause: mlc-009: use error caused or contributed to event.Note: manufacturer contacted customer in a follow-up call on 24-may-2024 to ensure that the initial concern was resolved - able to establish contact with customer who stated he was in contact with a general surgeon and was waiting for an appointment.Customer did state that he will be incurring cost.The customer stated that he is no longer using the trueplus pen needles.
Event or Problem Description
Consumer reported complaint for the trueplus pen needles.Customer stated that on (b)(6) 2024 while administering his insulin the pen needle had broken off and become stuck in his abdomen.The customer stated he had sought medical attention and had gone to the er.At the er customer was informed that he requires a surgeon as the needle was unable to be removed.Customer stated he was told that his bowels could be perforated by the needle.The er had referred customer to a surgeon, whom the customer has contacted and is awaiting an appointment to be scheduled.Customer stated he is looking for coverage of his medical expenses due the surgery that he needs to have.At the time of the call the customer did not report experiencing pain or bruising as a result of the needle being stuck in his abdomen.The package had not been opened or damaged when received by the customer.The customer has been using the pen needles for six months.The customer is using compatible a product and the pen needle is aligned properly.

• 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: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 19567535
• Report Number: 1000113657-2024-00261
• Device Sequence Number: 6948190
• Product Code: FMI
• UDI-Device Identifier: 00021292010799
• UDI-Public: (01)00021292010799
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 2I612
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/24/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 06/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown