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

Model Number CLICKFINE 32GX4MM DONGBAO 7CT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

The patient purchased the clickfine needle from the hospital.When the patient completed an insulin injection at home, the patient observed red spots, bleeding, on the injection site.This prompted the patient to stop using the needle.Several testing and documents were reviewed: bioburden report, endotoxin report, irradiation certificate, biocompatibiilty testing, manufacturing documentations.However, no abnormalities were found.The review of manufacturing history showed no abnormalities or deviations from the validated manufacturing process including the 100% in-process control for needle tip to cannula check prior to fitting of the protective cap.

Event Description

The patient purchased the clickfine needle from the hospital.When the patient completed an insulin injection at home, the patient observed red spots, bleeding, on the injection site.This prompted the patient to stop using the needle.

• 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: 18468515
• MDR Text Key: 332375221
• Report Number: 3002806818-2024-00005
• 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: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: CLICKFINE 32GX4MM DONGBAO 7CT
• Device Catalogue Number: 700000176
• Device Lot Number: 221618-02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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