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

Model Number	PNDL, 3BV TVH TP 32G 4MMTC 100CT 30/CS YELLOW
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were returned for evaluation.Evaluation in process.Note: manufacturer contacted customer in a follow-up call on 04-oct-2021 to ensure the customer¿s initial concern was resolved- unable to establish contact with customer who stated the pharmacy refused to replace the pen needles.Note: manufacturer made several attempts to contact customer to ensure the customer¿s initial concern was resolved- unable to establish contact with customer.
Event or Problem Description
Consumer reported complaint 32g pen needles were bent or warped.Son is calling on behalf of the customer.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 30-nov-2021: h3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: complaint was forwarded to supplier quality based on complaint's description for investigations, internal evaluation has been completed by the manufacturer.Visually inspected returned two needles: needles arrived with protective cover removed.Pen needle showed no signs of being bent, broken or warped.Plastic cover aligns with needle to properly remove it from the insulin pen.Needle dispenses properly with lab prefilled insulin pens.All (returned and retains) test results meets the requirements.Most likely underlying root cause: mlc-061: improper use/mishandle by end user.

• 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: 12673467
• Report Number: 1000113657-2021-00664
• Device Sequence Number: 20027399
• Product Code: FMI
• UDI-Device Identifier: 00021292012816
• UDI-Public: (01)00021292012816
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 11/30/2021

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 32G 4MMTC 100CT 30/CS YELLOW
• Device Catalogue Number: S5H01A32-100TC
• Device Lot Number: 0J604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/24/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 11/30/2021
• 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