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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lack of samples from customer.
Event or Problem Description
He had to use five or six different pen needles to properly inject his insulin.He claimed that the needles feel dull or blunt when inserting into the skin and are very painful and that the flow of insulin is not good and he had one get "clogged" when attempting to inject the insulin.Customer stated he only uses the pen needles once and is not attempting to reuse them.He does not have issues putting the pen needle on the pen.

• 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: 9184469
• Report Number: 9613304-2019-00072
• Device Sequence Number: 2460331
• Product Code: FMI
• UDI-Device Identifier: 10015482234321
• UDI-Public: (01)10015482234321(17)240501(10)Z58F3
• 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): 09/27/2019

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: 05/01/2019
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8647
• Device Lot Number: Z58F3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2019
• 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