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

Model Number PNDL, 5BV TVH TP 32G 4MM100CT 30/CS

Device Problem Material Twisted/Bent (2981)

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

Event Date 04/21/2023

Event Type  malfunction  

Event Description

Consumer reported complaint for the trueplus pen needles.Customer stated that the needles keep bending every time she takes her insulin.Customer is unable to verify the lot# of the needles because the pharmacy gives them to her in a ziplock bag of 30.Customer states that the needles are fine when she removes the caps, but when she uses them they are bent and is afraid they might break off in her.The customer is using compatible product and the pen needle is properly aligned.Pharmacy was contacted and provided the lot number of the pen needles.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

Internal report reference number: (b)(4).Pen needles were not returned for evaluation.Expected product not received customer returned incorrect pen needles lot #2f600-scrapped incorrect product.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.

Manufacturer Narrative

Sections with additional information as of 20-jul-2023: h6: updated fda¿s type, findings and conclusions codes.H10: pen needles were not returned for evaluation - customer returned incorrect pen needles.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: 16948903
• MDR Text Key: 315461141
• Report Number: 1000113657-2023-00275
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00021292010805
• UDI-Public: (01)00021292010805
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• 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 32G 4MM100CT 30/CS
• Device Catalogue Number: S6H01A32-100
• Device Lot Number: 2F614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/21/2023
• Date Manufacturer Received: 07/05/2023
• 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