MAUDE Adverse Event Report: HTL-STREFA S.A. TECHLITE PEN NEEDLE

Model Number	32G X 4MM
Medical Device Problem Codes	Infusion or Flow Problem (2964); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint from a user due to needles bending after being inserted in their skin.The user also claims they do not get the full amount of insulin and need to use a second needle.It was confirmed the patient applies the cap correctly by placing it straight on, injects at 90 degree angle and does not inject into scar tissue.

• Brand Name: TECHLITE PEN NEEDLE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 11831579
• Report Number: 9613304-2021-00018
• Device Sequence Number: 4491755
• Product Code: FMI
• UDI-Device Identifier: 00015482234324
• UDI-Public: (01)00015482234324(17)250901(10)A58T8
• 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): 04/20/2021

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: 09/01/2025
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8647
• Device Lot Number: A58T8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1