MAUDE Adverse Event Report: YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7CT; PEN NEEDLE

Model Number CLICKFINE 32GX4MM DONGBAO 7CT

Device Problem Material Twisted/Bent (2981)

Patient Problem Pain (1994)

Event Date 05/10/2023

Event Type  malfunction  

Manufacturer Narrative

The patient felt pain at the injection site after completing an insulin injection.The patient observed a "hook" on the needle tip.The needle was replaced with a new one and the therapy was completed without issue.The pain also gradually improved.Manufacturing review showed no abnormalities or deviations from the validated manufacturing process for the main batch 211659.The needle tip from the cannula is 100% controlled before the inner protective cap is fitted.No issues could be found.

Event Description

The patient felt pain at the injection site after completing an insulin injection.The patient observed a "hook" on the needle tip.The needle was replaced with a new one and the therapy was completed without issue.The pain also gradually improved.

• Brand Name: CLICKFINE 32GX4MM DONGBAO 7CT
• 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 ; 23 n echo park ct; mountain house, CA 95391 ; 5105796072
• MDR Report Key: 18160855
• MDR Text Key: 328415020
• Report Number: 3002806818-2023-00023
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/17/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: CLICKFINE 32GX4MM DONGBAO 7CT
• Device Catalogue Number: 700000176
• Device Lot Number: 211659-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• 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