BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KCH FETAL BLADDER DRAINAGE CATHETER

    MDR report key: 91199 · Received May 15, 1997

    Report

    Report Number
    MW1011312
    Event Type
    Malfunction
    Date Received
    May 15, 1997
    Date of Event
    April 23, 1997
    Report Date
    May 6, 1997
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN AMNIOCENTESIS TO CATHETERIZE THE FETAL BLADDER, THE FETAL BLADDER CATHETER (PIGTAIL CATHETER) BECAME LODGED IN THE TROCAR. THE CATHETER COULD NOT BE MOVED, AND THE PROCEDURE HAD TO BE CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KCH FETAL BLADDER DRAINAGE CATHETER FETAL BLADDER DRAINAGE CATHETER KOD ROCKET MEDICAL PLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other