MAUDE Adverse Event Report: HTL-STREFA S.A. 1. BRAND NAME 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 primig problems.Customer stated several pen needles failed to prime and dispense insulin.The user completed the injection using a replacement pen needle and reported no adverse health consequences.The pen injectors used was lantus solostar pen injector.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) and customers sample (10 pen needle).In these pen neeedles ack 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.Final recommendation of the hhe team: to report the event in the united states, where the event occurred.
Event or Problem Description
On (b)(6) 2026 htl-strefa inc.Received a phone call complaint.Customer stated several pen needles failed to prime and dispense insulin.Customer uses the lantus solostar pen injector.Customer did not suffer any mis dosing from the complaint.The customer stated it takes dialing units 2 to 3 times and then the insulin shoots out of the pen needle as if it's under pressure.We are providing replacement samples and the customer agreed to submit samples for investigation analysis.On 2026-03-23 sample under complaint has been returned for further evaluation.

• Brand Name: 1. 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: 24696137
• Report Number: 9613304-2026-00008
• Device Sequence Number: 10176817
• 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): 03/05/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male