24HR, ORAL SUCTION KIT, HP, 2HR.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE REPORTING FACILITY WAS UNABLE TO FIND THE GREEN FOAM THAT DETACHED FROM THE ORAL SWAB AND FELL INTO PATIENT'S MOUTH. PER REPORT, THE PATIENT DID NOT HAVE TEETH AND DID NOT BITE DOWN WHILE THE ORAL CARE SWAB WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTING FACILITY AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. NO ADDITIONAL INFORMATION WAS PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE REPORTING FACILITY WAS UNABLE TO FIND THE GREEN FOAM THAT DETACHED FROM THE ORAL SWAB AND FELL INTO PATIENT'S MOUTH.

Additional Manufacturer Narrative

THE REPORTING FACILITY RETURNED THE SAMPLE FOR EVALUATION AND THE CUSTOMER REPORTED ISSUE THAT THE GREEN FOAM DETACHED FROM THE SUCTION SWAB WAS CONFIRMED. THE SWAB STICK APPEARED TO HAVE A SMALL AMOUNT OF GLUE AT THE TIP WHERE THE GREEN FOAM WAS ATTACHED. THE ROOT CAUSE WAS RELATED TO A VENDOR PRODUCT ISSUE AND A SUPPLIER CORRECTIVE ACTION REPORT WAS OPENED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.