BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLARD MINI-BAL SAMPLING CATHETER

    MDR report key: 8989074 · Received September 11, 2019

    Report

    Report Number
    8030647-2019-00087
    Event Type
    Injury
    Date Received
    September 11, 2019
    Date of Event
    August 22, 2019
    Report Date
    September 11, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    OYI
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC. AVANOS MEDICAL INC. 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 · 1

    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 SEVENTH 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 8030647-2019-00086 FOR THE SIXTH 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787159 BALLARD MINI-BAL SAMPLING CATHETER VAP AIRWAY DIAGNOSTICS BAL-CATH OYI AVANOS MEDICAL INC. 143 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention