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

Model Number	PNDL, 3BV TVH TP 31G 8MMTC 100CT 30/CS BLUE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2020
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-009: poor tech-not familiar ifu.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
Customer reported complaint for pen needles.Customer indicated that some of the pen needles were different lengths and per information obtained from the call recording, the customer had also stated that the pen needles were bent.At the time of the call, the customer had felt well and did not report any symptoms.The package had not been open or damaged when received.Customer did not claim to be injured when using the pen needles and no medical attention was reported.

• 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: 10882149
• Report Number: 1000113657-2020-00845
• Device Sequence Number: 16823286
• Product Code: FMI
• UDI-Device Identifier: 00021292012809
• UDI-Public: (01)00021292012809
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180720
• 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): 11/22/2020

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 8MMTC 100CT 30/CS BLUE
• Device Catalogue Number: S5H01D31-100TC
• Device Lot Number: 9G617
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 11/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1