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

Model Number	31G X 6MM
Medical Device Problem Codes	Material Twisted/Bent (2981); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint concern bent needle through the hole which caused accidental needle stick injury of nurse.No information about performed test or health consequences were provided.Htl-strefa made several attempt to obtain additional information to the event.The evaluation of archival samples and device history records (dhr) review did not confirm any defects.Product involved in incidents was not returned to htl-strefa s.A.For further evaluation.On the provided photo we can see bent needle from the user end.The needle is exposed from safety pen needle.In the instruction for use there is below information in point 7.Insert the needle into the flat skin at a 90° angle in one continuous movement until the shield is fully recessed.Deliver the dose.Do not remove the needle until the dose has been completely delivered.Count to 10 before removing the needle from the skin to prevent drug leakage.Do not change the direction of the safety pen needle while it remains in the body as this can result in bending or breaking of the needle.We are aware that, the accidental injury might have led or might lead to the accidental blood exposure (abe).It is defined as an accident associated with exposure to blood, bloody fluids or other fluids, and might have caused or might cause serious infection in the injured third party.Due to fact that the event could potentially cause harm and taking into account that health care professional experience difficulties with using the device, we conclude this event should being reported.The final recommendation of hhe team is: to report the event in us where the event was occurred.
Event or Problem Description
On 04/01/2026 htl-strefa inc.Received an email complaint notification.Customer reported a needlestick at the facility.After you inject the insulin, the needle is retracting back but sticks out the side and caused a needlestick.Photo has been attached to the notification.On the provided photo we can see bent needle from the user end.The needle is exposed from safety pen needle.Htl-strefa made attempt to obtain additional information to the event circumstances.

• Brand Name: DROPSAFE SAFEY PEN NEEDLE
• Common Device Name: SAFEY 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: 24870589
• Report Number: 9613304-2026-00012
• Device Sequence Number: 9100508
• Product Code: FMI
• UDI-Device Identifier: 05907996091584
• UDI-Public: (01)05907996091584(11)250219(17)280201(10)F68D3
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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: Health Professional
• Device Model Number: 31G X 6MM
• Device Catalogue Number: 8162
• Device Lot Number: F68D3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2025
• 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: Unknown