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

Model Number	PNDL, 5BV TVH TP 31G 6MM100CT 30/CS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pen needles were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure that the initial concern was resolved - able to establish contact with customer's wife who stated the initial issue has been resolved.Wife stated that she had not been tightening the pen needle onto the pen.Wife still advised that customer's pen is not compatible with the pen needles.
Event or Problem Description
Consumer reported complaint for the trueplus pen needles (31g).Wife is calling on behalf of the customer.Wife stated that when she puts the pen needle onto the insulin pen, the needles bend.Customer is not using a compatible pen with the pen needles.The package had not been open or damaged when received by the customer.The customer has been using the product out of this package since (b)(6) 2022.At the time of the call the customer felt well and did not report any symptoms.No medical intervention related to the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 13-dec-2022: h6: updated fda¿s type, findings and conclusions codes.H10: pen needles were not returned for evaluation.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer using pen needles from the same lot.No abnormalities observed with retention samples.Most likely underlying root cause: mlc-009: use error caused or contributed to event.

• 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: 15756086
• Report Number: 1000113657-2022-00586
• Device Sequence Number: 12417081
• Product Code: FMI
• UDI-Device Identifier: 00021292010782
• UDI-Public: (01)00021292010782
• 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: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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: 06/30/2023
• Device Model Number: PNDL, 5BV TVH TP 31G 6MM100CT 30/CS
• Device Catalogue Number: S6H01C31-100
• Device Lot Number: 8G605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/18/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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