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

Model Number	PNDL, 3BV TVH TP 31G 5MM100CT 30/CS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for needle bent/broken/warped.The expected fasting blood glucose test result range is undisclosed.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.During the call blood test was not performed by the customer.The pen needle strip lot manufacturer¿s expiration date is 09/01/2023 and open vial date is (b)(6) 2019.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were returned for evaluation.Defect was detected: bent needle.Most likely underlying root cause: rc-074: manufacturing processing error.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated will get replacement products from pharmacy.

• 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: 9357951
• Report Number: 1000113657-2019-10168
• Device Sequence Number: 19392562
• Product Code: FMI
• UDI-Device Identifier: 00021292009045
• UDI-Public: (01)00021292009045
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/23/2019

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 31G 5MM100CT 30/CS
• Device Catalogue Number: S5H01B31-100
• Device Lot Number: Y56ZB7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Distributor Facility Aware Date: 10/23/2019
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1