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

Model Number	32G X 4MM
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Missing Value Reason (3192)
Date of Event	06/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lack of samples from customer.
Event or Problem Description
Customer submitted a problem because needle bending and general dissatisfaction and his lack of trust to the product.Patient has submitted pain and leakage of insulin when using victoza pen.He has assessed needles as the worse compare p those which he was used previously.He afraid that needle will bent and break inside the body.

• Brand Name: TECHLITE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; 95-03 5; PL 95-035
• MDR Report Key: 9184441
• Report Number: 9613304-2019-00070
• Device Sequence Number: 2323668
• Product Code: FMI
• UDI-Device Identifier: 00015482234324
• UDI-Public: (01)00015482234324(17)240201(10)Z46D3
• Combination Product (Y/N): N
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

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: No Information
• Device Expiration Date: 02/01/2019
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8647
• Device Lot Number: Z46D3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1