450 SAL EJECTOR 3283

Additional Manufacturer Narrative

ADDITIONAL INFORMATION AND THE SAMPLE HAVE BEEN REQUESTED BUT TO DATE HAS NOT YET BEEN RECEIVED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

Description of Event or Problem

THE CUSTOMER REPORTED THAT SEVERAL SECONDS AFTER THEY STARTED USING THE PRODUCT, THE BLUE CAP ON THE TIP HAD DROPPED INTO THE PATIENT'S MOUTH AND WAS SWALLOWED. THE CUSTOMER FURTHER ADDED THAT THE PATIENT DID NOT CHEW THE PRODUCT DURING USE AND THE VACUUM WAS SET AT 20 MMHG. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE BLUE CAP WAS REMOVED FROM THE PATIENT HOWEVER DETAILS OF HOW IT WAS REMOVED WAS NOT SHARED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

Description of Event or Problem

THE CUSTOMER REPORTED THAT SEVERAL SECONDS AFTER THEY STARTED USING THE PRODUCT, THE BLUE CAP ON THE TIP HAD DROPPED INTO THE PATIENT'S MOUTH AND WAS SWALLOWED. NO PATIENT IMPACT HAS CURRENTLY BEEN REPORTED AND THE DOCTOR WILL EXAM BY CT IF NECESSARY. THE CUSTOMER FURTHER ADDED THAT THE PATIENT DID NOT CHEW THE PRODUCT DURING USE AND THE VACUUM WAS SET AT 20 MMHG. ADDITIONAL INFORMATION RECEIVED ON 30-APR-2020 STATED THAT IT APPEARED THE CAP GOT INTO THE DIGESTIVE TRACT AND THE DOCTOR ASSUMED IT WOULD BE CARRIED OUT OF THE BODY NATURALLY. ALSO THE CUSTOMER MENTIONED IT WOULD ALREADY BE OUT. THE PATIENT HAS NO ABDOMINAL SYMPTOMS. A CT SCAN WAS NOT PERFORMED AND NO MEDICAL INTERVENTION WAS REQUIRED. IT IS NOT KNOWN HOW LONG THE CAP WAS WITHIN THE PATIENT'S BODY.

Additional Manufacturer Narrative

ADDITIONAL EVENT INFORMATION WAS PROVIDED BY THE THE CUSTOMER ON (B)(6) 2020 THEREFORE WAS UPDATED WITH THE NEW DETAILS.