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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial 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 - able to establish contact with customer and stated will get supply from place of purchase.
Event or Problem Description
Consumer reported complaint for bent pen needles.Advocate is calling on behalf of the customer.Customer stated she was unable to her take her insulin because a lot of the pen needles were bent.Customer stated the pen needles had been bent when she had opened the box.The package was not open or damaged when received.The customer feels well and did not report any symptoms.The customer did not need medical intervention related to the use of the pen needles.

• 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: 9587445
• Report Number: 1000113657-2020-00024
• Device Sequence Number: 2474084
• Product Code: FMI
• UDI-Device Identifier: 00021292009076
• UDI-Public: (01)00021292009076
• 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,other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2020

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 32G 4MM100CT 30/CS
• Device Catalogue Number: S5H01A32-100
• Device Lot Number: Z58B7
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1