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

Model Number	PNDL, 3BV TVH TP 32G 4MM100CT 30/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were returned for evaluation and sent to supplier quality to contact the manufacturer for investigation report.Supplemental report will be submitted once new information is provided.
Event or Problem Description
Consumer reported complaint for inaccurate dispense/aspiration.Customer was concerned that the pen needles were not dispensing her insulin.Customer stated that the issue occurred with seven pen needles - two this morning and five earlier in the week.The customer feels well and did not report any symptoms.Customer did not need medical intervention related to the use of the pen needles.
Additional Manufacturer Narrative
Sections with additional information as of 07-feb-2020: h6: updated fda's method, result, and conclusion codes.H10: pen needles were returned for evaluation.Defect was detected.Pen needles arrived without protective seal and with inner component either bent or broken off: can not align or dispense properly.H10: most likely underlying root cause: rc-41: user/mechanical stress.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.Product notification letter sent to contact customer care.

• 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: 9565102
• Report Number: 1000113657-2020-00011
• Device Sequence Number: 14187133
• Product Code: FMI
• UDI-Device Identifier: 00021292009076
• UDI-Public: (01)00021292009076
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/18/2020

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: 09/01/2023
• Device Model Number: PNDL, 3BV TVH TP 32G 4MM100CT 30/CS
• Device Catalogue Number: S5H01A32-100
• Device Lot Number: Y58ZB9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2020
• Distributor Facility Aware Date: 12/11/2019
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1