450 SAL EJECTOR 3283
Received May 4, 2015 · Event occurred Apr 28, 2015
Report 9612030-2015-00048 · MDR key 4745556
Device
Product problems
- Device Dislodged or Dislocated
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. A SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THE REPORTED ISSUE WAS CONFIRMED; THE TIP WAS DETACHED. THE TUBING AND THE TIP DID NOT CONTAIN ADHESIVE RESIDUES. THE ROOT CAUSE IS DUE TO NO ADHESIVE ON THE TUBING AND TIP. THE SAMPLE WAS PACKAGED WITHOUT PASSING THROUGH THE AUTOMATED PULL TEST MACHINE. AN AUTOMATED PULL TEST WAS SET UP IN THE OPERATION PROCESS FOR ALL SALIVA EJECTORS. A RE-ADJUSTMENT WAS MADE ON THE SOLVENT APPLICATOR AIRLINE THAT HELPS MAINTAINS THE CONSISTENCY OF THE SOLVENT APPLICATION PROCESS. IF ADDITIONAL INFORMATION IS RECEIVED WARRANTING FURTHER ANALYSIS, THE INVESTIGATION WILL BE RESUMED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2015 THAT A CUSTOMER HAD AN ISSUE WITH A SALIVA EJECTOR. THE CUSTOMER STATES THAT WHILE USING ON A PATIENT, THE TIP DISENGAGED. THE CUSTOMER FURTHER REPORTS THAT NOTHING FELL INTO THE PATIENT'S MOUTH.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.