MAUDE Adverse Event Report: HTL-STREFA S.A. TECHLITE PEN NEEDLES; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	232129
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer is using the techlite pen needles.The customer has been using the products for about a year.The customer was trying to deliver insulin and had a needle break off and lodge in her skin, and part of the needle is still inside the plastic cap.She can see the needle in her skin but does not want to seek medical attention to remove it because it will cost too much.It is in her lower abdomen on the right side.She does use this area often and alternates on both sides of her stomach.She keeps the needle at a 90-degree angle, and this is the first time she has had an issue.The customer wanted to know if the needle would just dissolve, and she wouldn't need to seek medical attention.It was explained to her that we cannot give medical advice and can only recommend that it is best to seek medical attention if needed.She refused to seek medical attention at this time.
Additional Manufacturer Narrative
Customer did not return complaint samples.Archival samples were evaluated.Dhrs were reviewed and no records confirming the defects were observed.Needles were viewed under the microscope and measured, and no defects were observed.Triple puncture testing was performed, and no needle bending or breaking was observed.Complaint not confirmed.If the customer returns any complaint products, the products will be tested and a follow-up mdr will be filed.

• Brand Name: TECHLITE PEN NEEDLES
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; pl-95035; ozorkow ; PL
• MDR Report Key: 21651985
• Report Number: 1832816-2025-00007
• Device Sequence Number: 7489523
• Product Code: FMI
• UDI-Device Identifier: 00015482232290
• UDI-Public: (01)00015482232290
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2025
• Report Date (Section F): 03/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 232129
• Device Catalogue Number: 232129
• Device Lot Number: E46A4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/26/2025
• Event Location: Home
• Date Report to Manufacturer: 03/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 130 KG
• Date Report Sent to FDA: 03/20/2025