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

Model Number	PNDL, 3BV TVH TP 31G 5MMTC 100CT 30/CS GREEN
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Needle Stick/Puncture (2462)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were returned for evaluation; no defect was detected.Needle showed no signs of being bent, broken, or warped.Plastic cover aligns with needle to properly remove it from the insulin pen.Needle dispenses properly with lab prefilled insulin pens.No defect found.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.
Event or Problem Description
Consumer reported complaint for bent and warped pen needle.The customer did report needles stick and bruising.Medical attention is not reported as a result.The product storage location is undisclosed.The pen needle lot manufacturer¿s expiration date is 06/30/2021 and open vial date is (b)(6) 2020.

• 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: 10535149
• Report Number: 1000113657-2020-00676
• Device Sequence Number: 3860188
• Product Code: FMI
• UDI-Device Identifier: 00021292012786
• UDI-Public: (01)00021292012786
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/15/2020

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: 06/30/2024
• Device Model Number: PNDL, 3BV TVH TP 31G 5MMTC 100CT 30/CS GREEN
• Device Catalogue Number: S5H01B31-100TC
• Device Lot Number: 9G614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Distributor Facility Aware Date: 08/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1