BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELEE TIP 8 FR GRAD MINI KIT

    MDR report key: 3904994 · Received June 9, 2014

    Report

    Report Number
    9612030-2014-00033
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A SUCTION CATHETER. THE CUSTOMER STATES THE CATHETER WAS TO BE USED ON A BRADYCARDIC INFANT AND THE CATHETER WOULD NOT SUCTION, TWO CATHETERS DID NOT WORK. IT WAS AN EMERGENCY SITUATION CONSIDERING THE INFANT WAS BRADYCARDIC. THERE IS NO FURTHER INFO AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335975 DELEE TIP 8 FR GRAD MINI KIT SUCTION CATHETER BSY COVIDIEN 140988 402391164X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK