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

Model Number	PNDL, 3BV TVH TP 31G 5MMTC 100CT 30/CS GREEN
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Pen needles were not returned for evaluation.Most likely underlying root cause: mlc-065: manufacturing or packaging defect.Note: manufacturer contacted pharmacist in a follow-up call to obtain additional information and find out customer's condition - able to establish contact.The pharmacist informed that tried to assisting customer to use product, but some of the insulin was dispensed, but not enough.No medical intervention was required and customer did not took any medication due to elevated blood results since not enough insulin was coming through pen.In order to assist further, the pharmacist got a competitor pen needle and watched customer's technique and using the pen needle successfully with the same lantus pen.Customer indicates the issue is not the lantus pen.Customer did not return any of the allege defective pen needles to the pharmacy and she only has the product box.Manufacturer advise to send what is available, a prepaid label will be send to get the box back.
Event or Problem Description
Consumer complaint was received through fda's medwatch program (mw5096220).Consumer reported complaint for pen needle not dispensing correct amount of insulin and the blood sugar elevated due to the dose not being administered correctly.The customer did not report symptoms and medical attention is not reported as a result of the product use.The product storage location is undisclosed.The pen needle lot manufacturers expiration date is 08/31/2021 and open vial date is undisclosed.Event description - medwatch: pt states that needle attached to insulin pen but she cannot push insulin through pen her blood sugar were elevated due to dose not being administered correctly.Pt has been injecting insulin pen quite awhile and has never had an issue in the past.Pt has been a diabetic for many years.She has been using this product for years.This particular time she had trouble with injecting her lantus insulin.The pen needle attached to the insulin pen fine, but the insulin would not inject through the needle.She tried several pen needles without success.Her blood sugar has been elevated due to the inability to receive the dose.
Additional Manufacturer Narrative
Sections with additional information as of 25-nov-2020: update: h6: updated fda's method, result, and conclusion codes.H10: preliminary testing completed.Complaint was forwarded to supplier for investigation.Retention testing completed and no defect found.Pen needles were returned for evaluation on 4-nov-2020; manufacturer visually inspected returned product (3): 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.No defect found.Returned product was forwarded to supplier for evaluation.Correction: d2: common device name from "system, test blood glucose, over the counter" to "hypodermic single lumen needle" (align with product code fmi).
Additional Manufacturer Narrative
Sections with additional information as of 15-jan-2021: h6: updated fda's conclusion code.H10: manufacturer's investigation has been completed.No abnormalities observed on returned product, retain samples, and review batch record.All the test results meets the requirements.Update most likely underlying root cause from mlc-065: manufacturing or packaging defect to mlc-009: user error caused or contributed to event.

• Brand Name: PEN NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10731408
• Report Number: 1000113657-2020-00776
• Device Sequence Number: 17165527
• Product Code: FMI
• UDI-Device Identifier: 00021292012786
• UDI-Public: (01)00021292012786
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health professional
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2021

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: 08/31/2024
• Device Model Number: PNDL, 3BV TVH TP 31G 5MMTC 100CT 30/CS GREEN
• Device Catalogue Number: S5H01B31-100TC
• Device Lot Number: 9I608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Distributor Facility Aware Date: 10/14/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/26/2020; 12/21/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/30/2020; 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1