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

Model Number	PNDL, 5BV TVH TP 31G 5MM100CT 30/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for inaccurate dispense/ aspiration of the 31g pen needles.Customer was concerned the pen needles are unable to administer her insulin because of not aspirating / inaccurate dispense.The package had not been open or damaged when received by the customer.This was not the first time the customer used the product out of this package; customer has been using since (b)(6) 2021.The customer is using compatible product and the pen needle is properly aligned.At the time of the call, the customer felt well and did not report any symptoms.Customer did not claim they were injured while using the pen needles and no medical intervention related to the use of the product was reported.
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 to ensure the initial concern is resolved - unable to establish contact with customer at this time.
Additional Manufacturer Narrative
Sections with additional information as of 15-feb-2022: d9: device available for evaluation.H3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: pen needles were returned, product evaluation unable to be performed: three used pen needles without the protective cover and cover cap; unable to ship to the manufacturer due to needle exposed.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer using pen needles from the same lot.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: 13003626
• Report Number: 1000113657-2021-00772
• Device Sequence Number: 4873295
• Product Code: FMI
• UDI-Device Identifier: 00021292010775
• UDI-Public: (01)00021292010775
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/15/2022

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: 06/30/2023
• Device Model Number: PNDL, 5BV TVH TP 31G 5MM100CT 30/CS
• Device Catalogue Number: S6H01B31-100
• Device Lot Number: 8G601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/17/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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