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

Model Number	31G X 8MM
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In the submitted notification, patient experienced lack of needles in the hub, bending needles and additionally one needle broke off in the skin.The needle was removed by the user.No medical intervention has been required due to the event.He did not suffer any misdosing or health consequences.Customer confirmed he follows the ifu and rotates injection sites.However we did not receive detailed information about patient injection technique.Complained problem could be connected also with unappropriated technique of insulin delivery including not proper attachments pen needles on the pen injector, not proper insulin storage, reuse of the needles.In the instruction of use added to every product box is helpful information how to make injection in proper way : make the injection as directed by your healthcare professional, do not bend the needle.Inject slowly (approximately 10 seconds).Do not withdraw the needle immediately after injection.Do not change the direction of the pen needle while it remains in the body as this can result in bending or breaking of the needle.The literature review suggest that each broken needle should be located and removed quickly and carefully.The complained defect was not confirmed in the internal evaluation of archival sample, and device history records (dhr) review.During evaluation of archival sample observed slight exceedance on the parameter - penetration force.Such defect may be the reason on increasing pain feeling during injection.However the patient does not report increased pain sensations.Product involved in the incident has been not returned to htl-strefa s.A.For further evaluation.Htl-strefa s.A.Recommended to consult healthcare professional for assistance in choosing the appropriate injection technique.The needle was removed by patient themselves, without medical or surgical intervention.Patient did not report health deterioration due event.However, the complained problems can be considered as the product malfunction, because needles had failures in regards of meet the performance specifications which caused adverse device experiences for user.The final recommendation of hhe team is: to report the event in us.
Event or Problem Description
On 12/10/2025 htl-strefa inc.Received a phone call complaint.Customer stated his pen needles are bending on contact with the skin.He also said a pen needle broke off into his skin and he had to remove it using tweezers.He uses humalog, lantus, and ozempic pen injectors.He also reported having 5 to 8 pen needle that did not have a needle present.He did not suffer any mis dosing or health consequences, only the needle that broke off that he removed.Customer confirmed he follows the ifu and rotates injection sites.We are providing replacement product, and he was not able to confirm if samples for investigation analysis would be available.Sample under complaint has been not returned of 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: 23815280
• Report Number: 9613304-2025-00014
• Device Sequence Number: 9350341
• Product Code: FMI
• UDI-Device Identifier: 00857273002237
• UDI-Public: (01)00857273002237(17)300101(10)F59B3
• 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): 12/10/2025

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: Lay User/Patient
• Device Model Number: 31G X 8MM
• Device Catalogue Number: 9209
• Device Lot Number: F59B3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2025
• 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