BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD CLOSED SUCTION SYSTEM, ADULTS,14 FR,DSE,MDI

    MDR report key: 16655994 · Received March 31, 2023

    Report

    Report Number
    8030647-2023-00063
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    March 5, 2023
    Report Date
    June 9, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038924700
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30134731, WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. THE SAMPLE WAS RECEIVED WITHOUT THE ORIGINAL PACKAGING. NO OTHER COMPONENTS RECEIVED. THE REPORTED ISSUE WAS A PIECE WAS SEEN STUCK INTO THE DUAL SWIVEL ELBOW (DSE) MATERIAL OF THE CLOSED SUCTION CATHETER. WHEN INSPECTED UNDER MAGNIFICATION, A CLEAR, HARDENED MATERIAL WHICH APPEARED CRACKED, OR A PIECE WAS BROKE OFF (THE PIECE THAT BROKE OFF WAS NOT RETURNED) WAS SEEN AT THE DSE AREA OF THE CLOSED SUCTION CATHETER. WHEN TRYING TO ADVANCE THE CATHETER THROUGH, THE CATHETER WAS GETTING STUCK. THE CLEAR, HARDENED MATERIAL CANNOT BE REMOVED. THE ROOT CAUSE WAS MANUFACTURING RELATED. ALL INFORMATION REASONABLY KNOWN AS OF 07-JUN-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, INC. 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

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 31-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, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, 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

    IT WAS REPORTED THERE WAS AN "EXTRA PIECE OF PLASTIC APPEARS TO BE BROKEN, OR A PORTION OF IT IS MISSING. STAFF UNSURE IF THIS PIECE OF PLASTIC WAS DISLODGED INTO THE PATIENT'S AIRWAY WHEN ATTEMPTING TO SUCTION THE PATIENT WITH THE DEVICE...NO PATIENT HARM REPORTED ON SUNDAY MARCH 5TH A DEFECTIVE INLINE SUCTION CATHETER WAS DISCOVERED ON A PATIENT. IT LOOKS AS THOUGH THIS BALLARD HAS AND EXTRA PIECE OF PLASTIC THAT COVERED THE WHOLE AREA OF WHERE IT WOULD CONNECT TO THE ETT [ENDOTRACHEAL TUBE]. THE NURSE AND THE RT [RESPIRATORY THERAPIST] WHERE NOT ABLE TO PASS THE SUCTION CATHETER THROUGH." ADDITIONAL INFORMATION RECEIVED 08-MAR-2023 STATED THE DEVICE WAS USE FOR APPROXIMATELY 2-HOURS. THE USER REPORTS THE DEVICE WAS NOT ALTERED IN ANYWAY PRIOR TO THE REPORTED INCIDENT OCCURRING. THE PATIENT HAD A BRONCHOSCOPY COMPLETED, THERE WERE NO FINDINGS OF ANY FOREIGN OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265333 BALLARD CLOSED SUCTION SYSTEM, ADULTS,14 FR,DSE,MDI VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 22108 30134731 00609038924700

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male