BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS CATHETER, 5F

    MDR report key: 5822424 · Received July 16, 2015

    Report

    Report Number
    1833117-2015-00001
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    April 2, 2015
    Report Date
    July 7, 2015
    Manufacturer
    CATHETER RESEARCH, INC.
    Product Code
    LKF
    PMA / PMN Number
    K032835
    Removal / Correction Number
    NONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PROBLEM WITH THE DEVICE AS STATED IS VERY IMPROBABLE. THE PLASTIC SHEATH IS USED TO AID THE INSERTION OF THE CATHETER INTO THE CERVIX. THE PLASTIC SHEATH IS BY DESIGN LOOSE ON THE CATHETER SHAFT DURING INSERTION INTO THE CERVIX. THE PLASTIC SHEATH INSIDE DIAMETER IS 4MM WHILE THE CATHETER SHAFT IS NO MORE THAN 2MM IN OUTER DIAMETER. THE USER MOST LIKELY FORGOT TO REMOVE THE SHEATH AT THE END OF THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    PROBLEM WITH THE DEVICE AS STATED IS VERY IMPROBABLE. THE PLASTIC SHEATH IS USED TO AID THE INSERTION OF THE CATHETER INTO THE CERVIX. THE PLASTIC SHEATH IS BY DESIGN LOOSE ON THE CATHETER SHAFT DURING INSERTION INTO THE CERVIX. THE PLASTIC SHEATH INSIDE DIAMETER IS 4MM WHILE THE CATHETER SHAFT IS NO MORE THAN 2MM IN OUTER DIAMETER. THE USER MOST LIKELY FORGOT TO REMOVE THE SHEATH AT THE END OF THE PROCEDURE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE "PLASTIC SHEATH REMAINED IN CERVIX AFTER REMOVAL OF CATHETER FOLLOWING PROCEDURE." MEDWATCH REPORT MW5042080.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE "PLASTIC SHEATH REMAINED IN CERVIX AFTER REMOVAL OF CATHETER FOLLOWING PROCEDURE." MEDWATCH REPORT MW5042080.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461672 HS CATHETER, 5F HS CATHETER LKF CATHETER RESEARCH, INC. TMI1154 J237E

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention