inforMED
MalfunctionDYN

*

Received Jan 3, 2012 · Event occurred Nov 29, 2011

Report 2408788 · MDR key 2408788

Device

Generic name

Saliva Ejector

Manufacturer

Tidi Products, Llc

Model number

9306

Catalog number

9306

Lot number

*

Product problems

  • Component Missing
  • Device Or Device Fragments Location Unknown

Patient

*

  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

PATIENT WAS ON VENTILATOR AND RN WAS USING TIDI SALIVA EXTRACTOR DURING CLEANSING OF PATIENT'S ORAL CAVITY. DURING THE PROCESS, THE RN NOTICED THAT THE TIP OF THE SALIVA EXTRACTOR WAS MISSING FROM THE DEVICE. THE RN DID AN IMMEDIATE SEARCH OF THE ORAL CAVITY AND WAS UNABLE TO LOCATE THE TIP. THE ATTENDING MD USED A GLIDE SCOPE FOR VISUALIZATION ABOVE THE ET TUBE TRACHEAL CUFF. THE TIP WAS NOT LOCATED. CHEST X-RAYS WERE COMPLETED AND THE TIP WAS NOT NOTED IN EITHER LUNG. PATIENT WAS EXTUBATED SUCCESSFULLY. TIP NOT LOCATED, PRESUMED TIP ENTERED STOMACH. PATIENT HAS RECOVERED AND HAS SUFFERED NO INJURY AS A RESULT OF THE TIP. ICU LEADERSHIP NOTED THAT THE OUTSIDE OF THE PACKAGING (BULK PACK) HAS A SMALL BOX STATING "WARNING! A LOOSE TIP CAN CREATE A CHOKING HAZARD. CHECK TIP BEFORE USE." CONCERN IS THAT THE RN IS GRABBING THIS NON-STERILE PRODUCT FROM A LARGE BULK PACK AND WILL NOT NOTICE THE WARNING. ATTEMPTS TO REMOVE THE TIP FROM OTHER DEVICES IN THE SAME PACK WERE UNSUCCESSFUL. ICU HAS REMOVED THIS PRODUCT FROM STOCK AND IS SOURCING A SINGLE PIECE ALTERNATIVE.