MAUDE Adverse Event Report: TRIVIDIA HEALTH INC PEN NEEDLE; 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	09/17/2020
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 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.
Event or Problem Description
Consumer reported complaint for bent pen needles.Wife is calling on behalf of the customer.The package was not open or damaged when received.Customer has been using the pen needles from this package for a few weeks.The customer is using compatible product and the pen needle is aligned properly.The customer feels well and did not report any symptoms.Customer did not claim they were injured using the pen needles and no medical intervention related to the use of the product was reported.Customer uses compatible lantus solostar and humalog kwikpen pen injectors.

• Brand Name: PEN NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10678472
• Report Number: 1000113657-2020-00747
• Device Sequence Number: 2990865
• Product Code: FMI
• UDI-Device Identifier: 00021292009045
• UDI-Public: (01)00021292009045
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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: 02/01/2024
• Device Model Number: PNDL, 3BV TVH TP 31G 5MM100CT 30/CS
• Device Catalogue Number: S5H01B31-100
• Device Lot Number: Z56C7
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1