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

Model Number PNDL, 5BV TVH TP 31G 6MM100CT 30/CS

Device Problems Material Twisted/Bent (2981); No Flow (2991)

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

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Additional report reference number: (b)(4).Pen needles were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2023 to ensure the replacement products resolved the initial concern, customer stated they are comfortable with the replacement products.

Event Description

Consumer reported complaint for the trueplus pen needles.Customer called and stated that she has two boxes of the 31g pen needles and with both boxes, she noticed that some of the needles are bent and some of the needles are not aspirating correctly; additional report reference number (b)(4).The package had not been open or damaged when received by the customer.The customer has been using the product for about one month.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.

Manufacturer Narrative

Sections with additional information as of 17-apr-2024: d9: device available for evaluation.H3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: pen needle was returned - customer returned 1 used pen needle without the protective cover and cover cap; unable to ship to the manufacturer due to needle exposed.Return product scrapped.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.Most likely underlying root cause: mlc-009: use error caused or contributed to event.

• 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: 18311055
• MDR Text Key: 330940565
• Report Number: 1000113657-2023-00603
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00021292010782
• UDI-Public: (01)00021292010782
• 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: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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 6MM100CT 30/CS
• Device Lot Number: 2H621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/21/2023
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• 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