BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, 8 F, ELBOW

    MDR report key: 12139644 · Received July 8, 2021

    Report

    Report Number
    8030647-2021-00023
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Report Date
    August 9, 2021
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30109615, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ONE SAMPLE DEVICE WAS RETURNED. THE ENTIRE DEVICE WAS VISUALLY INSPECTED FOR DAMAGES. THE POSITION OF THE THUMB VALVE WAS IN THE UPRIGHT POSITION. THE THUMB VALVE WAS PRESSED AND RELEASED MULTIPLE TIMES FOR FUNCTIONAL INSPECTION. EACH TIME AFTER RELEASE, THE THUMB VALVE RETURNED TO THE UPRIGHT POSITION. THE SAMPLE WAS THEN ATTACHED TO MOBIVAC SUCTIONING EQUIPMENT WITH THE SUCTION SET AT 120MMHG. WHILE STILL ENGAGED WITH THE MOBIVAC SYSTEM, THE DISTAL END OF THE CATHETER WAS THEN INSERTED IN A BEAKER OF WATER WITH BLUE DYE, THE SUCTIONING OCCUR WHEN THE THUMB VALVE WAS PRESSED WHILE THE THUMB VALVE WAS IN AN UNLOCKED/ OPENED POSITION. THE SUCTIONING DID NOT OCCUR WHEN THE THUMB VALVE WAS PLACED IN THE LOCKED/ CLOSED POSITION. THE DISTAL END OF THE CATHETER WAS INSPECTED FOR A BLOCKED SKIVE. THERE WAS NO BLOCKAGE IN THE SYSTEM. THE CATHETER BODY WAS FULLY EXTENDED AND EXAMINED. THERE WERE NO SIGNS OF DAMAGED/ PINCHED/ CURVED TUBING. THE CONTROL BODY, SUCTION ADAPTER AND SEAL CARTRIDGE AREA WERE FREE OF DAMAGES OR DEFECTS. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 09-AUG-2021 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 · 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 IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 08-JUL-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, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE SPUTUM COULD NOT BE SUCTIONED DURING SUCTIONING. NO PATIENT INJURY. IT WAS REPORTED BY HOMECARE PATIENT'S FAMILY. "IT WAS SUPPOSED THAT THE CATHETER WAS REPLACED FOR NEW ONE THAT WAS PREPARED AT THE PATIENT'S HOME IMMEDIATELY." ADDITIONAL INFORMATION RECEIVED 21-JUN-2021 STATED THE DEVICE WAS IN USE FOR LESS THAT 24-HOURS. THE DEVICE WAS MOST ALTERED LIKELY ALTERED FROM THE PREVIOUS ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030043 BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, 8 F, ELBOW VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY 208-4J 30109615

    Patients

    Seq Age Sex Outcome Treatment
    1