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

Model Number	PNDL, 3BV TVH TP 31G 8MM100CT 30/CS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were not returned for evaluation.Most likely underlying root cause: mlc-61: improper use / mishandled by end user.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for bent pen needles.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.The pen needle lot manufacturer¿s expiration date is 11/01/2023.Customer will hold on to 10 of the pen needles to send back to us and will go to her local pharmacy to seek a replacement.Customer has the flextouch and the kwik pen.Customer was informed that the flex touch is not a compatible device.Customer states she had the issue with both injectors.Customer states she does not believe that she got the correct dosage of insulin that day.
Additional Manufacturer Narrative
Sections with additional information as of 21-apr-2020: updated fda's method, result, and conclusion codes.Pen needles were returned for evaluation.No defect was detected.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated she sent back a handful of pen needles and that she is currently using a competitor product.

• 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
• MDR Report Key: 9871408
• Report Number: 1000113657-2020-00180
• Device Sequence Number: 3040603
• Product Code: FMI
• UDI-Device Identifier: 00021292009069
• UDI-Public: (01)00021292009069
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143437
• 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,Followup
• Report Date (Section B): 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/01/2023
• Device Model Number: PNDL, 3BV TVH TP 31G 8MM100CT 30/CS
• Device Catalogue Number: S5H01D31-100
• Device Lot Number: Y46ZK2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Distributor Facility Aware Date: 02/27/2020
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1