TIDI
Received Oct 25, 2019
Report 2182318-2019-00003 · MDR key 9242463
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE WAS DISCARDED BY CUSTOMER AND UNABLE TO BE EXAMINED. LOT CODE INFORMATION IS UNKNOWN. THE MANUFACTURING SUPPLIER (B)(4) WAS NOTIFIED OF THIS EVENT. MULTIPLE ATTEMPTS TO CONTACT CUSTOMER FOR PATIENT AND LOT CODE INFORMATION. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED. A LOT CODE WAS ABLE TO BE PROVIDED. THE PRODUCT LABEL STATES, "A LOOSE TIP CAN CREATE A CHOKING HAZARD. CHECK TIP BEFORE USE." REMAINING INVENTORY WAS INSPECTED WITH NO DEFECTS PRESENT. THE COMPLAINT HISTORY WAS REVIEWED WITH NO SIMILAR COMPLAINTS REPORTED WITHIN THE PAST 5 YEARS. THE SUPPLIER QUALITY INFORMATION WAS REVIEWED AND APPEARS TO BE UP-TO-DATE. DURING A RETROSPECTIVE REVIEW WITH THE FDA HELP DESK, IT WAS DETERMINED THAT THIS COMPLAINT WAS INITIALLY SENT TO THE TEST REGION AND NOT THE FDA PRODUCTION REGION. THEREFORE, THIS REQUIRED A RESUBMISSION OF THIS MDR.
Description of Event or Problem
BLUE TIP OF SALIVA EJECTOR CAME OFF DURING A DENTAL PROCEDURE. THE PROCEDURE WAS NEARLY COMPLETE WHEN THE PATIENT WAS ASKED TO CLOSE HIS LIPS AROUND THE SUCTION DEVICE FOLLOWING A RINSE. WHEN HE OPENED HIS MOUTH AGAIN THE BLUE TIP HAD COME OFF AND WAS GONE. HAD PATIENT TURN TO SIDE AND VISUALLY INSPECTED ORAL CAVITY, BUT IT COULD NOT BE RECOVERED. ASKED THE PATIENT IF HE FELT HE HAD BREATHED IT IN OR CHOKED ON ANYTHING, PATIENT DENIED ANY SYMPTOMS. ALSO DISPLAYED NO EVIDENCE OF RESPIRATORY DISTRESS. NO COUGHING, SP02% MAINTAINED ~98%. HE ALSO DID NOT REPORT NOTICING IF HE SWALLOWED ANYTHING. IMMEDIATELY WENT TO THE (B)(6) EMERGENCY DEPARTMENT FOR LATERAL AND ANTERIOR CHEST FILMS TO RULE OUT ASPIRATION. FILMS WERE NEGATIVE FOR THE SUCTION TIP AND RADIOLOGY CONFIRMED THE TIP WAS NOT IN THE LUNGS. LIKELY THE PATIENT SWALLOWED BAG. THE TIP. CHECKED AROUND 50 OTHER SALIVA EJECTORS FROM THE SAME DISPENSARY BAG AND COULD NOT GET A BLUE TIP TO COME OFF NO MATTER HOW HARD I TRIED. DURING A RETROSPECTIVE REVIEW WITH THE FDA HELP DESK, IT WAS DETERMINED THAT THIS COMPLAINT WAS INITIALLY SENT TO THE TEST REGION AND NOT THE FDA PRODUCTION REGION. THEREFORE, THIS REQUIRED A RESUBMISSION OF THIS MDR.