BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLARD MULTI-ACCESS PORT (MAP) CATHETER, DOUBLE SWIVEL Y

    MDR report key: 13651768 · Received March 2, 2022

    Report

    Report Number
    8030647-2022-00071
    Event Type
    Injury
    Date Received
    March 2, 2022
    Date of Event
    February 11, 2022
    Report Date
    March 2, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038200729
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 28 FEB 2022 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 COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 0

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED AT LEAST THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030647-2022-00072 FOR THE SECOND REPORT; REFER TO 8030647-2022-00073 FOR THE THIRD REPORT . IT WAS REPORTED THAT THERE WAS BREATHING DISTRESS OF THE INTUBATED PATIENT. IT WAS DETERMINED THAT THE CLOSED SYSTEM CATHETER (CSC) WAS BLOCKED AND COULD NOT SUCTION, DUE TO THE SUCTION PROBE BECOMING "STUCK" INSIDE THE MULTI-ACCESS PORT MANIFOLD. THE PATIENT IS COVID-POSITIVE AND THE CARER HAD TO DISCONNECT THE SYSTEM AND USED A "CONVENTIONAL PROBE" TO PERFORM SUCTION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2293436 BALLARD MULTI-ACCESS PORT (MAP) CATHETER, DOUBLE SWIVEL Y VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY AVANOS MEDICAL INC. 240168-5 UNKNOWN 00609038200729

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention