BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLARD CLOSED SUCTION ADULT, 12 FR, DSE

    MDR report key: 10870609 · Received November 19, 2020

    Report

    Report Number
    8030647-2020-00091
    Event Type
    Injury
    Date Received
    November 19, 2020
    Report Date
    November 19, 2020
    Product Code
    BSY
    UDI-DI
    00609038939056
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RQ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 19-NOV-2020 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. 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, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE PATIENT REPORTS THAT WHILE SUCTIONING HIMSELF THE CATHETER CAUSED HIM HARM AND HE "BLEED" AND HE EXPERIENCED PAIN IN HIS CHEST. THE PATIENT ALSO SAYS THAT THE DEVICE DOES NOT REACH THE BASE OF THE TRACHEA AND IT GOES ONLY SO FAR; THEREFORE, HE HAS TO PUSH THE CATHETER TO MAKE IT REACH FURTHER, CAUSING HIM TO LOSE AIR, FEEL ASPHYXIA AND HEADACHE. ADDITIONAL INFORMATION RECEIVED 06-NOV-2020 FROM THE PATIENT STATED THE PROBLEM WITH THAT CATHETER IS THE ELBOW SHAPE, IT IS BECAUSE THE BASE WHERE IT CONNECTS TO THE TRACHEOSTOMY IS SMALL. THAT'S WHY THE AIR ESCAPES AND SUFFOCATES [ME] "BECAUSE THE OXYGEN DOES NOT PASS COMPLETELY INTO THE LUNGS THROUGH THAT ESCAPE AND NEITHER DOES IT STAY FIXED IN THE POSITION THAT YOU CONNECT IT, BUT AS TIME GOES BY IT TURNS LITTLE BY LITTLE." ADDITIONALLY, THE ACCORDION SHAPE TUBE CONNECTED ON THE SIDE OF THE CATHETER THAT CONNECTS TO THE SLEEVE OF THE VENTILATOR, THAT SENDS AIR THROUGH THE TRACHEA TOWARDS THE LUNGS, MOVES FROM SIDE TO SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331580 BALLARD CLOSED SUCTION ADULT, 12 FR, DSE VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY 2160 UNKNOWN 00609038939056

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other