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

Model Number CLICKFINE 32GX4MM DONGBAO

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 08/03/2023

Event Type  Injury  

Manufacturer Narrative

The patient was given an aspart insulin injection using a clickfine pen needle.The next day, the patient felt itching on their skin.Symptom was observed to have improved when another brand needle was used in the next injection.Several testing and documents were reviewed: bioburden report, endotoxin report, irradiation certificate, manufacturing documentations.However, no abnormalities were found.

Event Description

The patient was given an aspart insulin injection using a clickfine pen needle.The next day, the patient felt itching on their skin.Symptom was observed to have improved when another brand needle was used in the next injection.

• Brand Name: CLICKFINE 32GX4MM DONGBAO
• 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: 17870551
• MDR Text Key: 324916805
• Report Number: 3002806818-2023-00015
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLICKFINE 32GX4MM DONGBAO
• Device Catalogue Number: 700000176
• Device Lot Number: 221489-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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