BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24FR TELEFLEX RUSCH SILICONE FOLEY 30MLBALLOON CATHETER 3WAY

    MDR report key: 7596081 · Received June 12, 2018

    Report

    Report Number
    MW5077801
    Event Type
    Injury
    Date Received
    June 12, 2018
    Date of Event
    May 23, 2018
    Report Date
    June 11, 2018
    Manufacturer
    TELEFLEX MEDICAL IDA BUSINESS & TECHNOLOGY
    Product Code
    KOD
    UDI-DI
    04026704334889
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO(2) 3WAY CATHETERS FROM SAME LOT HAD BALLOON RUPTURE. TWO SEPARATE LOCATIONS. USING A 60 ML SYRINGE TO INFLATE 30ML OF SALINE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437016 24FR TELEFLEX RUSCH SILICONE FOLEY 30MLBALLOON CATHETER 3WAY FOLEY CATHETER KOD TELEFLEX MEDICAL IDA BUSINESS & TECHNOLOGY 17KE44 04026704334889
    437017 24FR TELEFLEX RUSCH SILICONE FOLEY 30MLBALLOON CATHETER 3WAY FOLEY CATHETER KOD TELEFLEX MEDICAL IDA BUSINESS & TECHNOLOGY 17KE44

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention