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

Model Number	PNDL, 3BV TVH TP 32G 4MM50CT 45/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
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 03-jun-2021 to ensure the initial concern was resolved - able to establish contact with customer who stated that she did not contact distributor for replacement product.Customer stated that the pen needles are working as designed and that the initial concern has been resolved.
Event or Problem Description
Consumer reported complaint for the trueplus pen needles, stating some of the 32g pen needles did not accurately dispense her insulin.Customer is using compatible product and the pen needle is properly aligned.The package had not been open or damaged when received.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.Customer stated she had discarded the alleged defective pen needles.
Additional Manufacturer Narrative
Sections with additional information as of 24-aug-2021: h6: updated fda¿s type, findings and conclusions codes.H10: pen needles were not returned for evaluation.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
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 11992395
• Report Number: 1000113657-2021-00377
• Device Sequence Number: 3325035
• Product Code: FMI
• UDI-Device Identifier: 00021292010317
• UDI-Public: (01)00021292010317
• Combination Product (Y/N): N
• 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): 08/24/2021

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: 10/01/2022
• Device Model Number: PNDL, 3BV TVH TP 32G 4MM50CT 45/CS
• Device Catalogue Number: S5H01A32-050
• Device Lot Number: X56ZA6
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/19/2021
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1