MAUDE Adverse Event Report: YPSOMED AG CLICKFINE 31GX5MM DE; PEN NEEDLE

Model Number CLICKFINE 31GX5MM DE

Device Problem Material Twisted/Bent (2981)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 07/24/2023

Event Type  Injury  

Event Description

After using the mylife clickfine pen needles 5 mm 31 g, they no longer twist into the protective cap and must first be tightened.There is also bleeding and pain at the puncture site.

Manufacturer Narrative

After using the mylife clickfine pen needles 5 mm 31 g, they no longer twist into the protective cap and must first be tightened.There is also bleeding and pain at the puncture site.No tests or manufacturing reviews or inspections of products can be completed as the customer was not able to give any product information, such as lot number, and the product was not returned to the manufacturer for investigation.

• Brand Name: CLICKFINE 31GX5MM DE
• 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: 17599231
• MDR Text Key: 321691181
• Report Number: 3002806818-2023-00008
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/22/2023

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: Lay User/Patient
• Device Model Number: CLICKFINE 31GX5MM DE
• Device Catalogue Number: 700009649
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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