MAUDE Adverse Event Report: HTL-STREFA S.A. DROPLET PEN NEEDLE

Model Number	32G X 4MM
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In the submitted notification, there was reported drug dose administration problems.Customer has 20 confirmed failed pen needles out of her last 3 boxes.The user completed the injection using a replacement pen needle and reported no adverse health consequences.The user confirmed compliance with the instructions for use (ifu).The pen injectors used were tresiba and novalog.The insulin doses are closely correlated with the patient's condition and glycaemic control.Whether the patient has received adequate doses of insulin can be assessed throughout the day during glucose measurements.Considering the above, the administration of insulin is not indifferent (glucose monitoring) to the patient and cannot be overlooked.Concerns about the administration of a full or incomplete dose of insulin are monitored by patients on an ongoing basis, therefore the risk of serious health complications is low.Glycaemic control is the main measure of diabetic status assessment and is an important parameter of daily therapy.History of previous, similar events show that a level of confirmed defects of product in comparison to quantity sold is negligible, the ratio of the confirmed complaints is on very low level.The defect was observed during evaluation of archival sample - 12 pen needle with lack of patency were found.Information about defect was immediately forwarded to appropriate department.Capa actions has been introduced to the complained problem.Production process has been verify.No defects in dhr reviewed.Although no harm occurred in this event, blockage of a pen needle represents a malfunction of the device, as it failed to perform its intended function of enabling insulin delivery.If such a malfunction were to recur and remain undetected, it could potentially result in under-delivery or non-delivery of insulin, which may lead to serious deterioration of health.Based on the above, despite the absence of patient harm, the event is assessed as a reportable malfunction under fda mdr requirements.
Event or Problem Description
On 03/02/2026 htl-strefa inc.Received a phone call complaint.Customer stated her pen needles are failing to dispense the insulin during her injection.She has 20 confirmed failed pen needles out of her last 3 boxes.Customer confirmed the pen needle did not bend on user or non-user end while attaching pen needle to injector pen.She uses tresiba and novalog injector pens.Customer confirmed that she follows the ifu and rotates injection sites.She did not suffer any mis dosing or serious injury from the complaint.We are providing replacement samples and the customer agreed to submit samples for investigation analysis.Sample under complaint has not been returned for further evaluation.

• Brand Name: DROPLET PEN NEEDLE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer (Section G): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer Contact: justyna zemigala ; adamowek 7; ozorkow, 95-03-5 ; PL 95-035
• MDR Report Key: 24603265
• Report Number: 9613304-2026-00006
• Device Sequence Number: 18284846
• Product Code: FMI
• UDI-Device Identifier: 00857273002091
• UDI-Public: (01)00857273002091(17)300101(10)F58A4
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: 171982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 9215
• Device Lot Number: F58A4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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: Female