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

Model Number CLICKFINE 32GX4MM DONGBAO 7CT

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)

Patient Problems Pain (1994); Dizziness (2194)

Event Date 07/18/2022

Event Type  Injury  

Manufacturer Narrative

The patient reported pain at the injection site and dizziness upon use of the clickfine needle.The patient reported that the clickfine could not be screwed tightly onto the pen which led to liquid leakage.The symptoms lessened after taking oral drugs and using a screw on brand needle.It was noted that this is the first initial uses of the patient of the clickfine needle after switching from a local brand.Clickfine is supposed to be clicked onto the pen (pushed in rather than screwed in) which might have contributed to the connection issue and leakage.The customer didn't return any needles for investigation.Other investigation included a review for any internal deviations during production, which showed no abnormalities or deviations from the validated manufacturing process.Penetration force testing was also performed with 5 samples retained from the same batch number.None of the needles tested from the same batch reached beyond the maximum penetration force of 1.0n (max 0.7 per gb15811-2016).

Event Description

Starting on the 5th of july, the patient switched from a local brand needle to clickfine needle for long-term insulin glargine injection.On the (b)(6) 2022, the patient went to the hospital and reported that the dongbao clickfine needle could not be screwed tightly on the pen and this lead to liquid leakage.The patient had experienced dizziness and pain at the injection site.The symptom lessened after replacing another brand needle and taking oral drugs.

• Brand Name: CLICKFINE 32GX4MM DONGBAO 7CT
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): YPSOMED AG; brunnmattstrasse 6; burgdorf, bern CH-34 01; SZ CH-3401
• Manufacturer (Section G): YPSOMED AG; brunnmattstrasse 6; burgdorf, bern CH-34 01; SZ CH-3401
• Manufacturer Contact: clarisa tate ; 23 n echo park ct; mountain house, CA 95391 ; 5105796072
• MDR Report Key: 15366114
• MDR Text Key: 299353778
• Report Number: 3002806818-2022-00010
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CLICKFINE 32GX4MM DONGBAO 7CT
• Device Catalogue Number: 700000176
• Device Lot Number: 201255-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• 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