MAUDE Adverse Event Report: HTL-STREFA S.A. DROPSAFE SAFETY 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.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 (b)(6) 2026 htl-strefa inc.Received an email complaint notification.Customer stated: the needle came out of the side and stuck a nurse.We tested multiple ones and it happens with them all.Supposed to be a safety needle.Customer was called several times with no answer and no option for leaving a call back message.Email was sent for additional information.Sample under complaint has not been returned to htl-strefa until this report.
Event or Problem Description
On 03/23/2026 htl-strefa inc.Received an email complaint notification.Customer stated: the needle came out of the side and stuck a nurse.We tested multiple ones and it happens with them all.Supposed to be a safety needle.Customer was called several times with no answer and no option for leaving a call back message.Email was sent for additional information.On 2026-04-22 sample under complaint has been returned for further analysis.
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 sample, customers sample 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.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.

• Brand Name: DROPSAFE SAFETY PEN NEEDLE
• Common Device Name: SAFETY 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: 24870298
• Report Number: 9613304-2026-00011
• Device Sequence Number: 8998614
• Product Code: FMI
• UDI-Device Identifier: 05907996091584
• UDI-Public: (01)05907996091584(11)250127(17)280201(10)F68C1
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: F68D4, F68H8, F68C1
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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