It was reported that the ear syringe "does not pull back and stay at the full position" and that the syringe cannot be pushed to a "completed position." to date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.A sample was returned for evaluation and the reported problem/issue was confirmed.A circular piece of the device was found to be impacted which resulted in the plunger being difficult to use.A definitive root cause was unable to be determined.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
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