BALLARD MINI-BAL SAMPLING CATHETER

Additional Manufacturer Narrative

THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 10 SEP 2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

Description of Event or Problem

AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING 7 DIFFERENT PATIENTS. THIS IS THE SIXTH OF SEVEN REPORTS. REFER TO 8030647-2019-00081 FOR THE FIRST REPORT; REFER TO 8030647-2019-00082 FOR THE SECOND REPORT; REFER TO 8030647-2019-00083 FOR THE THIRD REPORT; REFER TO 8030647-2019-00084 FOR THE FOURTH REPORT; REFER TO 8030647-2019-00085 FOR THE FIFTH REPORT; REFER TO 8030647-2019-00087 FOR THE SEVENTH REPORT. IT WAS REPORTED THAT THIS IS ONE OF SEVEN PATIENTS THAT HAVE RECENTLY BEEN DIAGNOSED WITH INFECTIONS FROM THE SAME ORGANISM AT THE REPORTING HOSPITAL. THE HOSPITAL IS CONCERNED THAT THE INFECTION IS RELATED TO THE DEVICE.