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

Model Number	PNDL, 3BV TVH TP 31G 8MM100CT 30/CS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
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.Pharmacy is calling on behalf of the customer.Customer stated that the pen needles would bend when she attempted to inject her insulin.Customer was concerned that the product was unable to administer her insulin due to the bent needles.Customer stated that this was first time she used the product out of the package.The customer feels well and did not report any symptoms.Customer was not claiming she was injured and did not need any medical intervention related to the use of the pen needles.Customer is using a compatible lantus solar star pen with her 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: 9513152
• Report Number: 1000113657-2019-10248
• Device Sequence Number: 2695107
• Product Code: FMI
• UDI-Device Identifier: 00021292009069
• UDI-Public: (01)00021292009069
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Other
• Type of Report: Initial
• 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: 11/01/2023
• Device Model Number: PNDL, 3BV TVH TP 31G 8MM100CT 30/CS
• Device Catalogue Number: S5H01D31-100
• Device Lot Number: Y46ZK3
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2019
• Initial 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