inforMED
MalfunctionDYN

PREMIUM

Received Dec 18, 2014 · Event occurred Nov 10, 2014

Report 4371907 · MDR key 4371907

Device

Generic name

Saliva Ejector Suction Catheter

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.