BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANOS MIC KEY GASTROSTOMY FEEDING TUBE

    MDR report key: 20546051 · Received October 25, 2024

    Report

    Report Number
    MW5161693
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    October 17, 2024
    Report Date
    October 20, 2024
    Manufacturer
    AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AVANOS 12F 1.5 CM MICKEY BUTTON GASTROSTOMY FEEDING TUBE BALLOON SPONTANEOUSLY RUPTURED THREE WEEKS AFTER INSERTION. 1/2 OF THE RUPTURED BALLOON NOT FOUND/ RETAINED IN SITU. LOT NUMBER 30336813. EXP 7-17-2006. REFERENCE REPORTS: MW5161692, MW5161694.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302972 AVANOS MIC KEY GASTROSTOMY FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) 8140-12-1.5 30336813

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Other