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 problems with priming needle and difficulty with removing pen needle form pen injector.No serious deterioration in state of the health occurred due to complained issue.The patient claim that he follow the ifu however we did not receive detailed information about patient injection technique.The complained problems could be connected also with unappropriated technique of insulin delivery including not proper attachments pen needles on the pen injector, not proper insulin storage, reuse of the needles.If a pen needle is attached to a pen injector in an improper way (e.G., at an angle, or if hands are shaking), there is possibility for the needle to hit the metal cap of the ampule and cause needle bending or breaking.In fact, it is sufficient that the needle pierces the membrane in a slightly crooked way to have a reduction in its normal functionality and therefore a reduced amount of insulin released which could also culminate in an arrest of the drug release.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.On 2026-03-04 product involved in the event has been returned to htl-strefa s.A.For further evaluation.In the customer sample observed lack of patency in 3 pen needles.Problems with removing pen needle form pen injector by an outer cap were confirmed.2 pen needles observed with that issues in the archival sample and 2 in the customers sample.Information about defect was immediately forwarded to the complaint department.Capa actions regarding needle patency are ongoing.No defects observed during 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 (b)(6) 2026 htl-strefa inc.Received a phone call complaint.Customer stated several pen needles failed to dispense insulin.He said the insulin failed to prime.He also said the pen needles are difficult to remove from the pen injector, stating the protective cap fails to remove the pen needle following injection.He stated 6 pen needles have failed of the 20 pen needles used out the box of 100.Customer confirmed following the ifu and uses lantus solostar pen injector.He did not suffer mis dosing or health consequence from the complaint.We are providing replacement samples and customer agreed to submit samples for investigation analysis.On 2026-03-04 product involved in the event has been returned to htl-strefa s.A.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: 24603040
• Report Number: 9613304-2026-00005
• Device Sequence Number: 15595683
• Product Code: FMI
• UDI-Device Identifier: 00857273002091
• UDI-Public: (01)00857273002091(17)300101(10)E58ZB2
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171982
• 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): 02/02/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 9215
• Device Lot Number: E58ZB2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male