MAUDE Adverse Event Report: TRIVIDIA HEALTH INC PEN NEEDLES FG; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	PNDL, 3BV TVH TP 32G 4MMTC 100CT 30/CS YELLOW
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2020
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 on 20-oct-2020 to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.
Event or Problem Description
Consumer reported complaint for bent pen needles.Wife is calling on behalf of the customer.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.The test strip lot manufacturers expiration date is 10/31/2024 and open vial date is september 2020.

• Brand Name: PEN NEEDLES FG
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10795401
• Report Number: 1000113657-2020-00808
• Device Sequence Number: 1138493
• Product Code: FMI
• UDI-Device Identifier: 00021292012816
• UDI-Public: (01)00021292012816
• 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
• Report Date (Section B): 11/05/2020

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: 10/31/2024
• Device Model Number: PNDL, 3BV TVH TP 32G 4MMTC 100CT 30/CS YELLOW
• Device Catalogue Number: S5H01A32-100TC
• Device Lot Number: 9K601
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1