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 Needle Stick/Puncture (2462)

Event Date 08/24/2023

Event Type  Injury  

Manufacturer Narrative

The nurse's finger bled when it was punctured while taking off the outer protective cap of the clickfine during an insulin injection with a novopen.The cannula was found bent and stretched out of the needle hub.Review of manufacturing documentation showed no abnormalities or deviations from the validated manufacturing process for the main batch 221515.Assembly rocess review of the straightness check for the cannula is found to be 100% controlled before the inner protective cap is fitted.Non-conforming parts were automatically sorted out as expected.

Event Description

The nurse's finger bled when it was punctured while taking off the outer protective cap of the clickfine during an insulin injection with a novopen.The cannula was found bent and stretched out of the needle hub.

• 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 ; 32 wilson road; concord, MA 01742 ; 5105796072
• MDR Report Key: 17980445
• MDR Text Key: 326234679
• Report Number: 3002806818-2023-00019
• 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: 10/20/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: CLICKFINE 32GX4MM DONGBAO 7CT
• Device Catalogue Number: 700000176
• Device Lot Number: 221515-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• 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