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

Model Number	PNDL, 3BV TVH TP 31G 6MMTC 100CT 30/CS PURPLE
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 13-jan-2022 to ensure that the initial concern was resolved - able to establish contact with customer who stated that she is continuing to use the trueplus pen needles.Customer stated that she did not speak with her doctor regarding using compatible product.When asked if the initial concern had been resolved, customer had disconnected the call.No further information was able to be obtained.
Event or Problem Description
Consumer reported complaint for the trueplus pen needles, stating that the 31g pen needles were unable to administer her insulin due to inaccurate dispense.Customer stated this had occurred with 10-15 pen needles.Customer stated the package had not been open or damaged when received.Customer is not using compatible product: customer is using the basaglar pen injector.Customer stated that she has been using the basaglar pen injector with the trueplus pen needles for over 5 years, and that this is the first time she is experiencing an issue.Customer was advised to stop use of the pen needles and to contact her doctor to obtain compatible product.Customer declined to return the remaining pen needles and to provide her mailing address.Customer stated that she will continue to use the product.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.
Additional Manufacturer Narrative
Sections with additional information as of: 26-april-2022 updated fda's type of investigation, investigation findings, and investigation conclusions complaint was forwarded to supplier quality based on complaint's description for investigations, no product was returned to thi, internal evaluation has been completed by the manufacturer, reported defect not reproduced on retention samples.Most likely underlying root cause mlc-061: improper use/mishandle by end user.

• 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 13444013
• Report Number: 1000113657-2022-00050
• Device Sequence Number: 1545310
• Product Code: FMI
• UDI-Device Identifier: 00021292012793
• UDI-Public: (01)00021292012793
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180720
• 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): 04/26/2022

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: 09/30/2025
• Device Model Number: PNDL, 3BV TVH TP 31G 6MMTC 100CT 30/CS PURPLE
• Device Catalogue Number: S5H01C31-100TC
• Device Lot Number: 0J616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/06/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown