It was reported that the feeding syringe was "defective." no specific problem/issue with the feeding syringe was originally reported.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 problems/issues.A sample was returned for evaluation and a defect was unable to be determined from the sample.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on (b)(6)2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
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