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

Model Number NDL, PEN LDR TP 31G 6MM100CT 30/CS

Device Problem Material Twisted/Bent (2981)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/17/2023

Event Type  Injury  

Event Description

Consumer reported complaint for the trueplus pen needles.Customer stated that some of the pen needles are bent and that one of the pen needles had gotten stuck in her stomach; customer did not disclose the date this had occurred.Customer stated that her home health nurse had removed the pen needle from her stomach.No further details were provided.Customer stated that she had discarded the box the pen needles came in; lot information was not able to be provided.

Manufacturer Narrative

Internal report reference number: (b)(4).Pen needles were not returned for evaluation.Most likely underlying root cause: (b)(4): there was not enough information to determine the mlurc.Note: manufacturer contacted customer in a follow-up call on 30-mar-2023 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

• Brand Name: PEN NEEDLES FG
• Type of Device: 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: 16714832
• MDR Text Key: 313070850
• Report Number: 1000113657-2023-00198
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NDL, PEN LDR TP 31G 6MM100CT 30/CS
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/17/2023
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention