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)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Caller has been using devices for about a week and is complaining that she isn't feeling the insulin reacting with her pen needle the way that it does with her old ones.Caller stated the insulin is not releasing and she can't have her blood sugar that high, indicating she is not receiving the full dose.She is not re-using same pen needle.Not injecting in scarred tissue and not near navel area.Explained the return process and importance of sending back un-used ones.Replaced product and sent return label.
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 visually assessing the cannula under magnification under microscope.Light coming through the cannula was visible.Additionally, 10 randomly selected pen needles from the archival samples 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 and confirms the correctness of the pen needle assembly.Fluid flow was obtained in all tested pen needles.The defects under complaint were not confirmed in the archival samples and samples meet requirements of 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.
Additional Manufacturer Narrative
Complaint devices were returned for evaluation and forwarded to the manufacturer for further investigation.Returned complaint devices have been correctly assembled; no needle defects observed.Patency of cannula was verified by visual assessment in magnification under microscope; light coming through the cannula was visible.The defects under complaint were not confirmed in the returned samples and samples meet requirements of specification.Root cause analysis was not conducted as archival 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
• 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: 13053475
• Report Number: 1832816-2021-00016
• Device Sequence Number: 3912491
• 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): 01/26/2022

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 Expiration Date: 03/01/2026
• Device Model Number: 234132
• Device Catalogue Number: 234132
• Device Lot Number: B58D7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2021
• 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: Female