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

Model Number PNDL, 5BV TVH TP 31G 5MM100CT 30/CS

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Pen needles were returned - product evaluation in-process.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for the trueplus pen needles.Wife is calling on behalf of the customer.Customer stated that the 31g pen needles are bent.Customer stated the needles are bent prior to attaching to the pen injector.The package was not open or damaged when received by the customer.Customer has been using the pen needles out of this package for one week.The customer is not using compatible product.Customer stated that the incompatible product is not the issue, as if the needles are not bent they work as intended.At the time of the call the customer felt well and did not report any symptoms.No medical intervention related to the use of the product was reported.

Manufacturer Narrative

Sections with additional information as of 30-mar-2023: h3: was the device evaluated by the manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: pen needles were returned for evaluation.Returned product was forwarded to supplier quality and internal evaluation was performed by the manufacturer.No abnormalities observed with returned and retention samples.Most likely underlying root cause: mlc-061: improper use/mishandled by end user.

• 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: 16451642
• MDR Text Key: 310531575
• Report Number: 1000113657-2023-00112
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00021292010775
• UDI-Public: (01)00021292010775
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PNDL, 5BV TVH TP 31G 5MM100CT 30/CS
• Device Catalogue Number: S6H01B31-100
• Device Lot Number: 2F604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/02/2023
• Date Manufacturer Received: 03/08/2023
• 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: Initial
• Patient Sequence Number: 1