BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLARD CLOSED SUCTION SYSTEMS FOR NEONATES/PEDIATRICS, Y-ADAPTER

    MDR report key: 16375824 · Received February 14, 2023

    Report

    Report Number
    8030647-2023-00024
    Event Type
    Injury
    Date Received
    February 14, 2023
    Date of Event
    January 17, 2023
    Report Date
    April 4, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038938257
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 07 MAR 2023 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

    4581-APPROPRIATE CLINICAL SIGNS, SYMPTOMS, CONDITIONS TERM/CODE NOT AVAILABLE: ATELECTASIS. 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. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 14 FEB 2023 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. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4 THE ACTUAL SAMPLE FROM THE REPORTED EVENT WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE REVEALED THE TEARING ON THE SLEEVE STARTED FROM THE PEEP SEAL LOCATION. THE REPORTED EVENT COULD BE CONFIRMED AS REPORTED; HOWEVER, THE ROOT CAUSE IS UNDETERMINED. THE DEVICE HISTORY RECORD FOR LOT 30202148 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 02 APR 2023 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

    ADDITIONAL INFORMATION RECEIVED 19JAN2023 REPORTED, MID-SHIFT ON (B)(6) 2023, THE REGISTERED NURSE (RN) FOUND THE PLASTIC SLEEVE TO THE CLOSED SUCTION CATHETER (CSC) ¿OPEN NEARLY END TO END¿. THEY WERE UNSURE IF IT HAD BEEN THAT WAY BEFORE AS THE TEAR WAS ONLY VISIBLE ON ONE SIDE; THE PATIENT HAD BEEN SUCTIONED AT LEAST HOURLY FOR MOST OF THE DAY; THE CSC HAD BEEN IN USE FOR POSSIBLY 5 DAYS. THE PATIENT WAS EVALUATED FOR SEPSIS, A TRACH ASPIRATE (TA) WAS PERFORMED AND FOUND TO HAVE GRAM POSITIVE COCCI FOR WHICH THE INFANT WAS STARTED ON ANTIBIOTICS. A CHEST X-RAY (CXR) REVEALED AREAS OF ATELECTASIS THAT MAY OR MAY NOT HAVE BEEN ASSOCIATED WITH A PNEUMONIA; A PERIPHERAL BLOOD CULTURE WAS POSITIVE FOR ENTEROCOCCUS FECALIS, (CONSIDERED AN ABSOLUTE PATHOGEN); ARTERIAL BLOOD WAS NEGATIVE FOR ANY MICROBES. IT WAS ADDITIONALLY REPORTED, THERE WAS NO WAY TO DEFINITIVELY ASSOCIATE POTENTIAL CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION (CLABSI) WITH (TA) EXCEPT SAME GRAMS STAINED DESCRIPTION FOR ORGANISM. ADDITIONAL INFORMATION RECEIVED 06FEB2023 CLARIFIED, THE TA WAS NEGATIVE, PERFORMED ON (B)(6) 2023; THE BLOOD CULTURE WAS POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108377 BALLARD CLOSED SUCTION SYSTEMS FOR NEONATES/PEDIATRICS, Y-ADAPTER VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 197 30202148 00609038938257

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DA Female Required Intervention| L| O UNSPECIFIED ANTIBIOTIC