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

Model Number	236132
Medical Device Problem Codes	Material Fragmentation (1261); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Part 236132.Lot a56l6 - 2025-05-01.Customer is using the techlite pen needles and stated they were accidentally stuck.Customer has been using the product for about 30 days.A needle broke off and was lodged in his skin and he removed it.He did not seek medical attention since he was able to get the needle out of his skin and the needle was sterile when this happened.Caller stated the needle didn't bend, but the needle just "popped", and the insulin went everywhere, so he wasn't able to get the correct amount of insulin.He didn't stick the needle in any areas of calloused or hard skin or in the same place as a previous puncture.He didn't hold it in place for about five seconds because he didn't need it that long.I suggested holding it in place for about five seconds to ensure he gets the correct amount of insulin.Replaced product and sent return label.
Additional Manufacturer Narrative
Customer did not return complaint samples.Archival samples were evaluated.Dhrs were reviewed and no records confirming the defects were observed.Drag force and penetration tests were performed.The forces are within the required parameters by product specification.Needles were viewed under the microscope and measured, and no defects were observed.10 randomly selected pen needles from the sample were assembled on the pen injector.With every assembly attempt, droplets on the cannula were observed and injection of the applied dose can be seen.No defects observed.Triple puncture testing was performed, and no needle bending was observed.Complaint not confirmed.Rca not conducted.No capa.Complaint closed.

• Brand Name: TECHLITE PEN NEEDLES
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 18300804
• Report Number: 1832816-2023-00018
• Device Sequence Number: 3226113
• Product Code: FMI
• UDI-Device Identifier: 00015482236328
• UDI-Public: (01)00015482236328
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/11/2023
• Report Date (Section F): 12/11/2023

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 Expiration Date: 05/01/2025
• Device Model Number: 236132
• Device Catalogue Number: 236132
• Device Lot Number: A56L6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/14/2023
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 12/11/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Date Report Sent to FDA: 12/11/2023