PREMIUM
Received Dec 18, 2014 · Event occurred Nov 10, 2014
Report 4371907 · MDR key 4371907
Device
Generic name
Saliva Ejector Suction Catheter
Manufacturer
Crosstex International, Inc.Model number
*Catalog number
ZCB
Lot number
09/0/14 1
Product problems
- Detachment Of Device Component
- Component Falling
Patient
61 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE PATIENT WAS IN THE PROCEDURE ROOM FOR PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT. THE CLINICIAN WAS SUCTIONING THE PATIENT USING A SALIVA EJECTOR THAT WAS CONNECTED TO SUCTION TUBING. THE CLINICIAN REPORTED THAT THE BLUE TIP FROM SALIVA EJECTOR CAME OFF AND WAS IN THE PATIENT'S MOUTH. THE PHYSICIAN WAS ABLE TO KEEP THE TIP IN VIEW WITH THE ENDOSCOPE UNTIL ANESTHESIA ARRIVED TO SECURE AIRWAY, AND INTUBATE IF NEEDED. CODE WAS CALLED. ONE OF THE CODE/ANESTHESIA TEAM CLINICIANS WAS ABLE TO RETRIEVE THE TIP FROM THE PATIENT. THE PATIENT REMAINED STABLE THROUGHOUT INCIDENT AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AFTER THE PEG PROCEDURE WAS COMPLETED. THE SALIVA EJECTOR USED FOR THE PROCEDURE WAS SEQUESTERED. THE DEVICE WAS RETAINED AND SIMILAR LOTS WERE REMOVED FROM THE STOCK LOCATION.