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

Model Number	PNDL, 3BV TVH TP 31G 8MMTC 100CT 30/CS BLUE
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles (no lot number) were returned - 15 used pen needles without the protective cover and cover cap were returned, unable to ship to the manufacturer due to needle exposed.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer using pen needles from the same lot.Reported defect not reproduced on retention samples.Most likely underlying root cause: mlc-009: use error caused or contributed to event.Note: manufacturer contacted customer in a follow-up call on 07-dec-2021 to ensure that the initial concern was resolved - able to establish contact with customer who stated that replacement pen needles were obtained from her local pharmacy and that the product is working as intended.
Event or Problem Description
Consumer reported complaint of inaccurate dispense for the 31g pen needles.Customer stated that the pen needles did not dispense the insulin when ready to be administered.Customer stated that this occurred with twelve of the pen needles.The package had not been open or damaged when received by the customer.The customer is using compatible product 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 FG
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 13018278
• Report Number: 1000113657-2021-00781
• Device Sequence Number: 4963934
• Product Code: FMI
• UDI-Device Identifier: 00021292012809
• UDI-Public: (01)00021292012809
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/16/2021

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: 09/30/2025
• Device Model Number: PNDL, 3BV TVH TP 31G 8MMTC 100CT 30/CS BLUE
• Device Catalogue Number: S5H01D31-100TC
• Device Lot Number: 0J617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Distributor Facility Aware Date: 11/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown