MAUDE Adverse Event Report: HTL-STREFA S.A. TECHLITE PEN NEEDLE 31G X 8MM

Model Number	31G X 8MM
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Leak/Splash (1354); Dull, Blunt (2407); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer states that she has been a paramedic for 30yrs and she states she had an a1c of between 5-6 while using the comfort ez pen needles up until she began using the techlite pen needles on (b)(6) 2022 since then her a1c has increased to 7.1 per her physician and she feels that this is due to not being able to properly dose insulin due to the needles bending and not knowing how much insulin was being absorbed.She states that about 3-4d after starting the techlite one of the needles broke off and stayed in her stomach but that she was able to remove it without medical intervention.She has not started any new medications or had any changes in doses.She is type 2 diabetic.She can see the bubble when she is priming and she holds the needle in place to the count of 7 or 8.When pulling the needle she finds that it is bent at 90° and/or realizes that there is insulin is on her clothes she feels like end of needle is dull.She gives injections into her stomach at 90° and her bg continues to rise and then she finds that the insulin has not gone into her and that the needle had bent or she finds that it has leaked out and not been absorbed and she cannot give more insulin because she does not know how much of the insulin actually went into her body so she has to wait and see what it does.

• Brand Name: TECHLITE PEN NEEDLE 31G X 8MM
• Common Device Name: PEN NEEDLE
• 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: 15083754
• Report Number: 9613304-2022-00008
• Device Sequence Number: 3978369
• Product Code: FMI
• UDI-Device Identifier: 00015482238315
• UDI-Public: (01)00015482238315(17)261201(10)B46ZP1
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2022

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 Model Number: 31G X 8MM
• Device Catalogue Number: 8646
• Device Lot Number: B46ZP1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• 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