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

Model Number	32G X 4MM
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint due to lack of insulin patency.Sometimes the insulin injection is possible only after usage of 3rd needle.The patient uses lantus and victoza, she uses the needles only once and has not noticed the needles bending at the needle tops.

• Brand Name: TECHLITE
• Common Device Name: PEN NEEDKES
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 8563863
• Report Number: 9613304-2019-00052
• Device Sequence Number: 2359480
• Product Code: FMI
• UDI-Device Identifier: 00015482234324
• UDI-Public: (01)00015482234324(17)230301(10)Y58J3
• 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): 03/13/2019

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: Lay User/Patient
• Device Expiration Date: 03/01/2023
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8647
• Device Lot Number: Y58J3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1