6FR,STYLET,ET TUBE

Additional Manufacturer Narrative

UPDATED H6: INVESTIGATION FINDINGS (C). UPDATED H6: INVESTIGATION CONCLUSIONS (D).

Description of Event or Problem

ACCORDING TO THE FACILITY, "THE CURRENT STYLET THAT WE ARE RECEIVING IS A DIFFERENT PRODUCT THAN WE HAVE USED IN THE PAST. THE NEW STYLET IS VERY FLIMSY AND HAS MADE THE PROCEDURE OF INTUBATING BABY'S VERY DIFFICULT AND IS A SAFETY CONCERN." FACILITY REPORTS LESS SUCCESSFUL INTUBATIONS.

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY, "THE CURRENT STYLET THAT WE ARE RECEIVING IS A DIFFERENT PRODUCT THAN WE HAVE USED IN THE PAST. THE NEW STYLET IS VERY FLIMSY AND HAS MADE THE PROCEDURE OF INTUBATING BABY'S VERY DIFFICULT AND IS A SAFETY CONCERN." FACILITY REPORTS LESS SUCCESSFUL INTUBATIONS. NO ADDITIONAL INFORMATION AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.