inforMED
MalfunctionBYY

TUBING SUCTION CONNECTOR

Received Feb 27, 2025 · Event occurred Jan 7, 2025

Report 21478613 · MDR key 21478613

Device

Generic name

Tube, Aspirating, Flexible, Connecting

Model number

71-C512

Catalog number

71-C512

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PATIENT NEEDED TO HAVE A BEDSIDE EGD (ESOPHAGOGASTRODUODENOSCOPY) FOR SUSPECTED VARICEAL BLEEDING. WHEN PREPPING FOR INTUBATION, THE SUCTION TUBING WAS NOTED TO NOT FIT CORRECTLY TO THE END OF THE YANKAUER, CAUSING THE YANKAUER TO FALL OUT AND FOR SUCTION TO NOT BE EFFECTIVE. THE PATIENT WAS AT HIGH RISK OF ASPIRATION DURING INTUBATION, SO THIS COULD HAVE RESULTED IN HARM TO THE PATIENT. WE ENDED UP TAPING THE YANKAUER TO THE TUBING, WHICH DID WORK. HOWEVER, WHEN THE GI (GASTROINTESTINAL) BLEED TEAM CAME TO DO THE ENDOSCOPY, THE SUCTION THAT THEY NEEDED TO EFFECTIVELY DO THEIR JOB WAS ALSO NOT WORKING AS INTENDED BECAUSE THE SUCTION TUBING WAS FALLING OFF OF THEIR EQUIPMENT. THEY ENDED UP FINDING SOME OF OUR OLD TUBING THAT CONNECTS TO THE WALL SUCTION, SO THE PROCEDURE WAS NOT IMPEDED. HOWEVER, THEY WERE UNABLE TO EFFECTIVELY DO THEIR JOB WITH THE NEW TUBING. OF NOTE: THERE HAVE BEEN MULTIPLE REPORTS OF THIS IN THE PAST WEEK. WE ARE WORKING WITH THE MFG. WHO STATES THEY WILL BE RECALLING CERTAIN PRODUCTS. MANUFACTURER RESPONSE FOR TUBE, ASPIRATING, FLEXIBLE, CONNECTING, DEROYAL (PER SITE REPORTER). WILL BE SUBMITTING RECALL. MANUFACTURER RESPONSE FOR TUBE, ASPIRATING, FLEXIBLE, CONNECTING, DEROYAL (PER SITE REPORTER). WILL BE ISSUING RECALL MANUFACTURER RESPONSE FOR TUBE, ASPIRATING, FLEXIBLE, CONNECTING, DEROYAL (PER SITE REPORTER). THEY ARE AWARE OF THE ISSUE AND ARE GOING TO ACTIVATE A RECALL.