inforMED

FIRST STEP BEDSIDE PRECLEAN KIT

Received Feb 24, 2015 · Event occurred Feb 24, 2015

Report MW5041020 · MDR key 4563426

Device

Generic name

Preclean Kit

Manufacturer

Cygnus Medical

Model number

TK200

Lot number

EX20150514A

Product problems

  • Microbial Contamination of Device

Patient

Not reported

  • Bacterial Infection
  • Test Result

Narrative

Description of Event or Problem

A FEW WEEKS AGO IT WAS REPORTED BY MY FACILITY'S INFECTIOUS DISEASE PHYSICIAN THAT THERE WAS A NOTABLE UPTAKE IN STENOTROPHOMONAS MALTOPHILIA SEEN IN BRONCHOSCOPY CASES, PARTICULARLY WASHES AND LAVAGES, BASED ON A SERIES OF LAB RESULTS RETURNED.