BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLARD TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, DOUBLE SWIVEL ELBOW

    MDR report key: 11648079 · Received April 12, 2021

    Report

    Report Number
    8030647-2021-00011
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    March 21, 2021
    Report Date
    April 12, 2021
    Product Code
    BSY
    UDI-DI
    00609038989693
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 30064660 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 07 APR 2021 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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

    IT WAS REPORTED THAT THE CATHETER WAS KINKED AND AFTER USE, "POSSIBLY CAUSED SOME BLEEDING IN THE PATIENT." THE DEVICE WAS USED FOR TWO HOURS BEFORE BEING REPLACED AT 1AM ON (B)(6) 2021, AND THE PATIENT IMPROVED OVER THE COURSE OF THE SHIFT AND BY 8PM ON (B)(6) 2021, HE "WAS MUCH BETTER WITH ONLY MINIMALLY BLOOD STAINED SPUTUM." IT WAS FURTHER REPORTED BY THE NURSE THAT "THE PATIENT ONLY HAD SALINE NEBS AND TO TREAT IT AND I SWITCHED HIM DOWN TO A SMALLER 12FR CATHETER TO HELP MINIMIZE IRRITATION TO HIS AIRWAY FOR THE TIME BEING. THE MAIN TREATMENT WAS JUST SPOTTING THAT THE CATHETER WAS THE PROBLEM AND REMOVING IT." NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546381 BALLARD TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, DOUBLE SWIVEL ELBOW VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY 22703-5 30064660 00609038989693

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other UNKNOWN ENDOTRACHEAL TUBE