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 Codes	Defective Component (2292); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were returned - product evaluation in-process.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 who stated he received replacement pen needles from his supplier and that they are working as intended.
Event or Problem Description
Consumer reported complaint for the 31g trueplus pen needles.Customer stated that the needle falls off when putting the cap back on after administering his insulin.Customer was concerned as several have fallen off and he stated that it could be dangerous if a human or animal stepped on it.Customer has been using the product out of this package for one week.The customer is using compatible product and the pen needle is properly aligned.Customer stated the package had not been open or damaged when received.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.
Additional Manufacturer Narrative
Sections with additional information as of 11-jul-2022: h3: was the device evaluated by the manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: pen needles were returned, product evaluation unable to be performed: 7 pen needles without the protective cover and cover cap; 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.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: 14621311
• Report Number: 1000113657-2022-00320
• Device Sequence Number: 20044516
• Product Code: FMI
• UDI-Device Identifier: 00021292010782
• UDI-Public: (01)00021292010782
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 07/11/2022

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: 8G606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/11/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/11/2022
• 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