MAUDE Adverse Event Report: HTL-STREFA S.A. TECHLITE PEN NEEDLE 32G X 4MM; PEN NEDLE

Model Number	32G X 4MM
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Patient felt as if they weren't getting enough insulin and started to use the same pen needles that they're used to.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.
Event or Problem Description
Patient felt as if they weren't getting enough insulin and started to use the same pen needles that they're used to.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.
Additional Manufacturer Narrative
Analysis of the archival sample was conducted on (b)(6) 2021 for compliance with the parameters established in product specifications zn-2014/htl- 810.02, rev.26.During testing, particular attention was paid to needle patency and quality of needle.No deviations were observed in the archival sample which could cause the defect under complaint - the product meets the requirements of product specifications.The tests of customer sample were performed on (b)(6) 2022 for compliance with the parameters established in product specifications zn-2014/htl- 810.02 revision 26.The patency of cannula was verified by visual assessment in magnification on microscope with the same rules as archival sample.Light coming through the cannula was visible.There were no defects that could contribute to arising the problem under complaint in customer sample test.
Event or Problem Description
Patient felt as if they weren't getting enough insulin and started to use the same pen needles that they're used to.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.

• Brand Name: TECHLITE PEN NEEDLE 32G X 4MM
• Common Device Name: PEN NEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer (Section G): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer Contact: justyna zemigala ; adamowek 7; ozorkow, 95-03-5 ; PL 95-035
• MDR Report Key: 13043136
• Report Number: 9613304-2021-00031
• Device Sequence Number: 5409919
• Product Code: FMI
• UDI-Device Identifier: 00015482234324
• UDI-Public: (01)00015482234324(17)260301(10)B58D7
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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: 32G X 4MM
• Device Catalogue Number: 8647
• Device Lot Number: B58D7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female