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	Hyperglycemia (1905)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In the submitted notification, there was reported a problem with administering the dose which will consequently lead to hyperglycaemia customer stated her pen needles are failing to dispense full dose of insulin.The user was able to reduce her levels with another injection.The pen injectors used were humalog and lantus solostar pen injector.No medical intervention has been reported due to complained issue.We reasonably conclude that there are a lot of factors may have impact for blood glucose level.For example lifestyle, eating habits, stimulants used, and medications taken.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 hospitalization or medical intervention was reported, the reported increase in blood glucose level (hyperglycaemia) represents an adverse clinical effect that may result from inadequate insulin delivery.Additionally, patency problems were observed in archival sample.Although no hospitalization or medical intervention was reported, the reported increase in blood glucose level (hyperglycaemia) represents an adverse clinical effect that may result from inadequate insulin delivery.Therefore the event has been assessed as serious and reportable.
Event or Problem Description
On 03/16/2026 htl-strefa inc.Received a phone call complaint.Customer stated her pen needles are failing to dispense full dose of insulin.Customer said most of the pen needles she has used from her current box have failed to dispens.Customer confirmed through glucose freestyle monitoring system that her sugar had spike to 200 plus.She was able to reduce her levels with another injection.She did not seek medical attention and did not suffer any major health consequence.She uses humalog and lantus solostar pen injectors.Customer confirmed priming pen needles prior to injection and follows the ifu.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: 24773757
• Report Number: 9613304-2026-00009
• Device Sequence Number: 6133144
• 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): 03/16/2026

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: F58A4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2024
• 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: Female