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

Model Number	232129
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint devices were not returned for evaluation.Device history records were reviewed and no records confirming the defect were observed.Archival samples were evaluated by the manufacturer by viewing needles under a microscope and measured.Points were sharp and bevel length was within specifications.No defects were observed.Drag force and penetration force tests were conducted on archival sample.The needles were assembled in testing machine and puncture was made in polyurethane pad imitating human skin.Drag force and penetration force were within specification.Root cause analysis was not conducted as archival sample evaluation did not reveal any nonconformities.No capa initiated.If complaint devices are returned, they will be forwarded to the manufacturer for further investigation.
Event or Problem Description
Customer sent email to report issue and arkray followed up with customer via phone to gather more information.Part 232129.Lot a46z8 - 2025-09-01.Customer reported they received a box of techlite 12mm x 29g pen needles from the walgreen's pharmacy on (b)96) 2021 for her victoza insulin pen.She claims she has probably wasted half of what she has used so far because they will not pierce her skin.She claims she looks like she has been beaten and abused across her abdomen.In one evening, she went through six needles to get one that would go into her skin.She claimed that injecting her insulin should not be this painful.She is not injecting near her navel.She is not re-using needles.Needles do not appear to be barbed, and appear to be fine, but when she is trying to inject the needle, it appears to bend.Bevel appears to be fine.Explained the replacement and return process.Replaced needles and sending a return label.

• 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: 12314098
• Report Number: 1832816-2021-00014
• Device Sequence Number: 4002696
• Product Code: FMI
• UDI-Device Identifier: 00015482232290
• UDI-Public: (01)00015482232290
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/10/2021
• Report Date (Section F): 08/13/2021

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: 09/01/2025
• Device Model Number: 232129
• Device Catalogue Number: 232129
• Device Lot Number: A46Z8
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/20/2021
• Device Age: 10 MO
• Event Location: Home
• Date Report to Manufacturer: 08/13/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2021
• 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
• Date Report Sent to FDA: 08/13/2021