Additional information was added to d9, h3, h4, and h6.Corrections: b5 (describe event or problem) b5: the previous quantity that was initially submitted was two (2).The exact quantity that was received for evaluation was seven (7) one-link needle-free iv connectors.H10: seven (7) actual devices were received for evaluation.A visual inspection was performed, and it was noted that the sterile packaging was damaged.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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