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

Model Number	235131
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product involved in incident was returned for evaluation and forwarded to the manufacturer for further evaluation.Evaluation results are pending.Arkray will file a follow-up report when the evaluation is complete.
Event or Problem Description
The customer stated that he injected himself, and he's not sure if it was a 90-degree angle, and the needle broke off in his skin in the navel area.The customer said this is his first time seeing this happen and he has been using this product for a while.The customer did seek medical attention at urgent care, but they told the customer to go to the er.The customer stated that he has mobility issues, so he didn't go.I asked if the customer inserted the needle straight in and out or a at 90-degree angle.Customer said straight, but he wasn't sure because he doesn't measure it all the time.He stated that he did try picking the needle out using a tweezer.I advised the customer to seek medical attention if he was not able to remove the needle with a tweezer.Replaced the pen needles and sent a return label and advised of return the product for further investigation.
Additional Manufacturer Narrative
Device history records were reviewed.No records confirming the complained defects were observed.Archival and returned samples were evaluated.Needles were viewed under the microscope and measured and no defects were observed.Drag force and penetration tests were performed and no defects were observed.No defects that could be the cause of the complaint were observed during evaluation of archival and returned samples.The complaint is not confirmed.

• 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: 21604459
• Report Number: 1832816-2025-00005
• Device Sequence Number: 21136306
• Product Code: FMI
• UDI-Device Identifier: 00015482235314
• UDI-Public: (01)00015482235314
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025
• Report Date (Section F): 03/19/2025

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: 235131
• Device Catalogue Number: 235131
• Device Lot Number: D56K6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/18/2025
• Event Location: Home
• Date Report to Manufacturer: 03/19/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 03/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Date Report Sent to FDA: 03/19/2025