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 Swelling/ Edema (4577)

Event Date 08/15/2023

Event Type  Injury  

Manufacturer Narrative

The patient reported pain during an insulin injection by a nurse.The nurse observed redness and swelling at the injection site afterwards.Upon inspection of the needle, it was found to have a blunt or bent needle tip.The nurse replaced the needle to complete the injection.There were no issues with the new replacement needle.The review of production documents and in-process controls showed no abnormalities or deviations from the validated manufacturing process.

Event Description

The patient reported pain during an insulin injection by a nurse.The nurse observed redness and swelling at the injection site afterwards.Upon inspection of the needle, it was found to have a blunt or bent needle tip.The nurse replaced the needle to complete the injection.There were no issues with the new replacement 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 no echo park ct; mountain house, CA 95391 ; 5105796072
• MDR Report Key: 18134889
• MDR Text Key: 328109851
• Report Number: 3002806818-2023-00021
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 201103-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2020
• 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