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

Model Number	234132
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint products were not returned for evaluation.Dhr's were reviewed and no records confirming the defect were observed.Archival samples were evaluated.Needles were viewed under a microscope and measured, and no defects were observed.Drag force and penetration were tested on archival samples and no issues occurred during testing.Archival samples meet specification requirements.
Event or Problem Description
Customer has two boxes of our techlite pen needles, 32-gauge x 4mm, light green color, 100 count, and she stated she has used about 20 from the box.Part 234132.Lot a58x2 - 2025-10-01.Caller stated they are dull, and they will not break through the skin.She says she must push the needles a little to break into the skin.I asked the customer at what angle she is injecting the needles and she stated 90 degrees.I asked her if she is injecting into any scar tissue and she stated no.She said she has done this for about 20 years now and she has used our product before and never had this issue.Customer continued to use devices until one worked properly.I explained to the customer i was going to be replacing both boxes and sending them a return label.I explained once they receive the new boxes to use that prepaid label to send us both boxes back for testing.Replaced devices and sent return label.
Additional Manufacturer Narrative
Returned complaint products 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 returned complaint products.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 both archival and returned sample evaluation did not reveal any nonconformities.No capa initiated.

• 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: 12033940
• Report Number: 1832816-2021-00012
• Device Sequence Number: 4166584
• Product Code: FMI
• UDI-Device Identifier: 00015482234324
• UDI-Public: (01)00015482234324
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/01/2025
• Device Model Number: 234132
• Device Catalogue Number: 234132
• Device Lot Number: A58X2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 07/20/2021
• 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: Life Threatening