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

Model Number	32G X 6MM
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Caller sets at two units to release the air then dials up to the dosage to the insulin amount that he's supposed to take.He stated that the plunger was locked and he was not able to press it down.He would remove the pen needle then screw it on then the insulin would release.Same thing happened on two different insulin pens, so he believes the issue is the pen needles.The user confirmed he removes the cover from the needle first then twists it on the insulin pen.Then he would remove the cover to reveal the top needle.He would adjust the dial to two units to release the air bubble, but it would jam.He was not able to release the air bubble or insulin.He also reported finding one bent needle after removing the cover.

• Brand Name: TECHLITE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow 95-03 5; PL 95-035
• MDR Report Key: 9309377
• Report Number: 9613304-2019-00079
• Device Sequence Number: 16634656
• Product Code: FMI
• UDI-Device Identifier: 10015482236325
• UDI-Public: (01)10015482236325(17)231201(10)Y46ZP5
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2019

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: 12/01/2023
• Device Model Number: 32G X 6MM
• Device Catalogue Number: 8648
• Device Lot Number: Y46ZP5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1