BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLARD TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, T-PIECE

    MDR report key: 11049558 · Received December 21, 2020

    Report

    Report Number
    8030647-2020-00122
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Report Date
    December 21, 2020
    Product Code
    BSY
    UDI-DI
    00609038947013
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 21 DEC 2020 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

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 8030647-2020-00119 FOR THE FIRST REPORT; REFER TO 8030647-2020-00120 FOR THE SECOND REPORT ; REFER TO 8030647-2020-00121 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER HAD A LOOSE CONNECTION AND "POPPED OFF" AT PATIENT CONNECTION. THERE WAS ALARM AWARENESS AND THE CATHETER WAS REAPPLIED OR SWITCHED OUT FOR ANOTHER LIKE CLOSED SUCTION CATHETER. NO PATIENT INJURY, OR ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512516 BALLARD TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, T-PIECE VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY 2270135 UNKNOWN 00609038947013

    Patients

    Seq Age Sex Outcome Treatment
    1