MAUDE Adverse Event Report: YPSOMED AG MY CLICKFINE 32GX4MM DE; PEN NEEDLE

Model Number MY CLICKFINE 32GX4MM DE

Device Problem Material Twisted/Bent (2981)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/05/2023

Event Type  malfunction  

Manufacturer Narrative

A user has observed that some of the my life click fine 4mm needles have a metal tip sticking out of the side.This causes her to get pricked whenever she handles the needles.The review of manufacturing history showed no abnormalities or deviations from the validated manufacturing process related to the described error pattern from the main batch 2216131.A 100% automatic sorting, in-process testing for the cannula cartridge end (wobble circle) straightness before peel foil seal was also reviewed.There were no issues found.

Event Description

A user has observed that some of the my life click fine 4mm needles have a metal tip sticking out of the side.This causes her to get pricked whenever she handles the needles.

• Brand Name: MY CLICKFINE 32GX4MM DE
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): YPSOMED AG; brunnmattstrasse 6; burgdorf, bern 3401 ; SZ 3401
• Manufacturer (Section G): YPSOMED AG; brunnmattstrasse 6; burgdorf, bern 3401 ; SZ 3401
• Manufacturer Contact: clarisa tate ; 32 wilson road; concord, MA 01742 ; 5105796072
• MDR Report Key: 16824732
• MDR Text Key: 314107134
• Report Number: 3002806818-2023-00005
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K171984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MY CLICKFINE 32GX4MM DE
• Device Catalogue Number: 3200923
• Device Lot Number: 221631-04
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female