It was reported that a needle broke off of the syringe while medication was being administered by a nurse.According to the unit manager, the device is new to the staff and the nurse "had difficulty using the product to draw the insulin and feels the needle may have bent in the process." after the needle broke off, it was reportedly removed from the patient's arm.A syringe-specific defect was not indicated at the time of the originally report and no serious injury or adverse impact to a patient or a user was 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 problem/issue.Two (2) samples in new condition were returned for evaluation.Visual and functional testing was unable to reproduce or confirm the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) 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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