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

Model Number	PNDL, 5BV TVH TP 31G 8MM100CT 30/CS
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were returned for evaluation.Product testing was performed and no defect found.Most likely underlying root cause: mlc-073: user not familiar with system ifu.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2021 to ensure that the initial concern was resolved - able to establish contact with customer who stated he is using a different brand and has not yet returned to the pharmacy to obtain the replacement.
Event or Problem Description
Consumer reported complaint of inaccurate dispense for the 31g pen needles.Complaint was initially reported via e-mail and customer was contacted by telephone.Customer stated he was unable to depress the plunger and dispense the insulin.Customer stated the package had not been open or damaged when received.Customer was using compatible product (humalog kwikpen) and the pen needle was properly aligned.At the time of the call the customer felt well and did not report any symptoms.Customer did not claim to be injured while using the pen needles and no medical intervention related to the use of the product was reported.

• Brand Name: PEN NEEDLES
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 11488116
• Report Number: 1000113657-2021-00175
• Device Sequence Number: 2955585
• Product Code: FMI
• UDI-Device Identifier: 00021292010799
• UDI-Public: (01)00021292010799
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/15/2021

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: 05/31/2023
• Device Model Number: PNDL, 5BV TVH TP 31G 8MM100CT 30/CS
• Device Catalogue Number: S6H01D31-100
• Device Lot Number: 8F600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Distributor Facility Aware Date: 02/16/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1