It was reported that the foam was found to be outside of the cap, but inside the packaging.This was noted before use, just after the package was opened.The minicap was not used by the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.This is report five of six.
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(b)(4).(b)(6).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was returned and visually inspected.The minicap was returned not in its original packaging, but all components were present and the set was assembled according to procedure.Although all of the components were present, the sponge was found to be out of the cap and was smaller than usual.The reported event was duplicated when a sponge smaller than specified was assembled into the cap, iodine was applied, and when the cap was moved, the sponge came out of it.The device did not meet product specifications related to this event.The cause of this event was determined to be a manufacturing issue.This was further investigated through a capa.The cause of the reported event was determined to be the size of the sponge provided by a supplier and the handling by operators since the packaged device was being shaken by operators to accommodate the packaging, resulting in the sponge coming out of the cap.As a result, the supplier was notified of the issue and the operators were retrained in order to eliminate the shaking practice.Should additional relevant information become available, a supplemental report will be submitted.Same patient/event as (b)(4).
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