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

Model Number	234132
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer had no complaint devices left to return.Archival samples were evaluated.Dhrs were reviewed and no records confirming the defects were observed.Patency of cannula was verified by visual assessment in magnification on microscope.Light coming through the cannula was visible.10 randomly selected pen needles from the archival 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, 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.Complaint not confirmed.Rca not conducted.No capa.Complaint closed.
Event or Problem Description
Part 234132, lot c58k9, 2027-07-01 - 100ct.The caller states that the needles are blocked, and no liquid is coming out, and he sometimes needs to use up to three needles to do an injection.Caller uses needles right away without priming and doesn't prime needles because insulin is expensive.The caller does not have any unused needles left to return.He does have ones that did not work, but are used, but i advised him not to return those.Replaced devices for customer.

• 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
• Manufacturer (Section G): HTL-STREFA S.A.; adamowek 7; 95-035 ozorkow; PL
• Manufacturer Contact: tom speikers ; 5182 w 76th street; minneapolis, MN 55439 ; 9526463168
• MDR Report Key: 16787930
• Report Number: 1832816-2023-00006
• Device Sequence Number: 12121469
• Product Code: FMI
• UDI-Device Identifier: 00015482234324
• UDI-Public: (01)00015482234324
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 234132
• Device Catalogue Number: 234132
• Device Lot Number: C58K9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male