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

Model Number	31G X 8MM
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.As per additional information the blood tests were performed.No health consequences occurred, blood tests results were negative.The evaluation of archival 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 had occurred.
Event or Problem Description
On 05/08/2025 htl-strefa inc.Received an email complaint notification from (b)(6).Customer stated: the needle bent through the hole and poked a staff member.No additional information for complaint is available at time of registration.Communication via email and voicemail was sent to the customer for additional information.We are currently waiting for a response.Additional information has been provided to the complaint notification: whether the nurse has any medical consequences related to the injury? no.Whether the patient and nurse were examined? yes, the nurse and the patient were both examined at local urgent care and test results as of today are negative for both nurse and patient.Are samples under complaint available? yes, i emailed return label for samples to the customer.Sample under complaint has not been returned to htl-strefa until this report.
Event or Problem Description
On (b)(6) 2025 htl-strefa inc.Received an email complaint notification from (b)(6).Customer stated: the needle bent through the hole and poked a staff member.No additional information for complaint is available at time of registration.Communication via email and voicemail was sent to the customer for additional information.We are currently waiting for a response.Additional information has been provided to the complaint notification: whether the nurse has any medical consequences related to the injury? no.Whether the patient and nurse were examined? yes, the nurse and the patient were both examined at local urgent care and test results as of today are negative for both nurse and patient.Are samples under complaint available? yes, i emailed return label for samples to the customer.Sample under complaint has been returned to htl-strefa on (b)(6) 2025.
Additional Manufacturer Narrative
The complaint concern bent needle through the hole which caused accidental needle stick injury of nurse.As per additional information the blood tests were performed.No health consequences occurred; blood tests results were negative.The evaluation of archival sample, returned sample and device history records (dhr) review did not confirm any defects.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 had occurred.Mdr number 9613304-2025-00006 was submitted to fda.

• 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: 22084141
• Report Number: 9613304-2025-00006
• Device Sequence Number: 6906897
• Product Code: FMI
• UDI-Device Identifier: 05907996091591
• UDI-Public: (01)05907996091591(11)240503(17)270501(10)E68M1
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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 8MM
• Device Catalogue Number: 8163
• Device Lot Number: E68M1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown