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); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/24/2023
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 evaluation is complete.
Event or Problem Description
Part 236132.Lot c58f6 - 2027-04-01.Customer was giving injection and was able to prime the needle, but when she went to inject the insulin, it would not inject, and when she pulled the syringe out, the needle stayed in her skin.She was able to pull the needle out of her skin.She will start a new box of pen needles and return this one to us for investigation.Replaced devices and sent return label.
Event or Problem Description
Part 236132.Lot c58f6 - 2027-04-01.Customer was giving injection and was able to prime the needle, but when she went to inject the insulin, it would not inject, and when she pulled the syringe out, the needle stayed in her skin.She was able to pull the needle out of her skin.She will start a new box of pen needles and return this one to us for investigation.Replaced devices and sent return label.
Additional Manufacturer Narrative
Devices were returned on 2/8/2023 and forwarded to the manufacturer for further investigation.Dhr was reviewed and no records of defects were observed.Archival and returned samples were tested by visual assessment in magnification on microscope and no defects were observed.Also, 10 randomly selected pen needles from both samples were assembled on the pen injector.With every attempt, droplets on the cannula were observed and injection of the applied dose can be seen, which is visible on the paper and confirms the correctness of the pen needle assembly on the pen and the patency of the needles.Fluid flow was obtained in all tested pen needles.Also, triple puncture tests were performed and no defects were observed.Complaint not confirmed.Rca not conducted as complaint was not confirmed.No capa.Htl filed mdr in us.Complaint closed.

• Brand Name: TECHLITE PEN NEEDLES
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; 95-035 ozorkow; PL
• MDR Report Key: 16356817
• Report Number: 1832816-2023-00003
• Device Sequence Number: 20412643
• Product Code: FMI
• UDI-Device Identifier: 00015482236328
• UDI-Public: (01)00015482236328
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/27/2023
• Report Date (Section F): 02/27/2023

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 Model Number: 236132
• Device Catalogue Number: 236132
• Device Lot Number: C58F6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/24/2023
• Event Location: Home
• Date Report to Manufacturer: 02/27/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 02/27/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Date Report Sent to FDA: 02/27/2023