BEUDAMED
    FDA Adverse Event Death Summary report: N

    BALLARD MULTI-ACCESS PORT CLOSED SUCTION SYSTEM FOR ADULTS, 16 F, DSE, MDI

    MDR report key: 8982745 · Received September 10, 2019

    Report

    Report Number
    8030647-2019-00080
    Event Type
    Death
    Date Received
    September 10, 2019
    Report Date
    May 26, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: BASED ON THE SAMPLE RECEIVED AND COMMUNICATION WITH THE REPORTER, THE ORIGINAL DEVICE INFORMATION WAS REPORTED TO AVANOS INCORRECTLY. D1 AND D4 HAVE BEEN UPDATED BASED ON THIS NEW INFORMATION. DUE TO THE NOVEL COVID-19 VIRUS OUTBREAK AND PANDEMIC, AVANOS MEDICAL HAS DECIDED AS A DEVICE MANUFACTURER TO NOT ASSESS ANY CONTAMINATED SAMPLES THAT HAVE BEEN RETURNED TO THE LAB UNTIL FURTHER NOTICE. THIS DECISION IS IN THE BEST INTEREST OF OUR STAFF AND PERSONNEL TO ENSURE THEIR SAFETY. ALL INFORMATION REASONABLY KNOWN AS OF 26 MAY 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. 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). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    A USED SAMPLE HAS BEEN RETURNED. THE INVESTIGATION REMAINS IN PROGRESS AT THIS TIME. ALL INFORMATION REASONABLY KNOWN AS OF 08 MAY 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. 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). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    PER ADDITIONAL INFORMATION RECEIVED FROM FACILITY. THERE WAS NO DISCONNECTION OF THE DEVICE. DEVICE CODE: "DISCONNECTION" IS REMOVED. ALL INFORMATION REASONABLY KNOWN AS OF 09 OCT 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). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    SAMPLE RECEIVED DOES NOT MATCH WHAT WAS REPORTED BY THE CUSTOMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Description of Event or Problem · 0

    PER ADDITIONAL INFORMATION RECEIVED 17 SEP 2019, THE CLOSED SUCTION CATHETER KINKED AND WOULD SUCTION INTERMITTENTLY THROUGH OUT THE NIGHT, CAUSING THE PATIENT TO DESATURATE. THE REPORTER CLAIMS IT WAS DIFFICULT TO RETRIEVE THE CATHETER FROM THE ENDOTRACHEAL (ET) TUBE. THE CLOSED SUCTION CATHETER WAS REMOVED THE NEXT MORNING AND REPLACED FOR ANOTHER SYSTEM AND THE PATIENT ACHIEVED GOOD VENTILATION AS A RESULT OF THE CHANGE. THE PATIENT HAD A MEDICAL HISTORY OF LEUKEMIA, RESPIRATORY DISTRESS AND ULTIMATELY PASSED AWAY FROM MENINGITIS. PER THE CLINICIAN, THE PATIENT DEATH WAS NOT CAUSED OR CONTRIBUTED TO BY THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. 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. 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 COMP-(B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A MALFUNCTION OF THE DEVICE LEADING TO LOSS OF VENTILATION AND DESATURATION OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED 23 AUG 2019 THE PATIENT CONDITION WAS LISTED AS "LISTERIA MENINGITIS, DVE [EXTERNAL VENTRICULAR SHUNT] PLACEMENT, VENTILATED, INTUBATED." THE PATIENT WAS ALSO LISTED AS DECEASED, NO CAUSE OF DEATH PROVIDED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777687 BALLARD MULTI-ACCESS PORT CLOSED SUCTION SYSTEM FOR ADULTS, 16 F, DSE, MDI VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 240168-5 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death