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

Model Number	NDL, PEN LDR TP 31G 5MM100CT 30/CS
Medical Device Problem Codes	Incomplete or Missing Packaging (2312); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
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-9: user error caused or contributed to event.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 she discarded products.
Event or Problem Description
Consumer reported complaint that some of the true plus pen needles are missing the needle.Mother is calling on behalf of the customer.Mother also stated that after customer administers his insulin, the needle feels like a fish hook is coming out of his skin, and the needles have burrs on them.Customer is not claiming they were injured or had a negative reaction from using the sharp.No medical intervention related to the use of the sharp was reported.At the time of the call, the customer felt well and did not report any symptoms.Mother is not seeking replacement, just calling to have complaint documented.Requested customer send some of the pen needles back for investigation.
Additional Manufacturer Narrative
Corrected sections as of 17-jan-2020: h10: most likely underlying root cause changed from "mlc-9: user error caused or contributed to event" to "mlc-61: improper use / mishandled by end user".Additional information sections as of 17-jan-2020: h4: added device manufacture date.H6: updated fda method, result, and conclusion codes.Complaint was forwarded to supplier quality based on complaint's description for investigations.No product was returned to thi.Internal evaluation has been completed by the manufacturer and no abnormalities observed.Most likely underlying root cause: mlc-61: improper use / mishandled by end user.

• 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: 9481372
• Report Number: 1000113657-2019-10232
• Device Sequence Number: 3999527
• Product Code: FMI
• UDI-Device Identifier: 00096295129106
• UDI-Public: (01)00096295129106
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/17/2020

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: 11/01/2023
• Device Model Number: NDL, PEN LDR TP 31G 5MM100CT 30/CS
• Device Catalogue Number: S5002B31-100
• Device Lot Number: Y56ZF5
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/20/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1