BEUDAMED
    FDA Adverse Event Other Summary report: N

    COIL CATH C CA2

    MDR report key: 3982599 · Received July 23, 2014

    Report

    Report Number
    3009211636-2014-00021
    Event Type
    Other
    Date Received
    July 23, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    COVIDIEN MANUFACTURING SOLUTIONS SA
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    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)(6) 2014, THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THERE WAS A DISCONNECTION OF THE CATHETER'S PLASTIC ADAPTER. NO TITANIUM ADAPTOR WAS USED FOR THIS PATIENT. AN INFECTION RISK WAS SUSPECTED AND AN ANTIBIOTIC TREATMENT WAS ADMINISTERED FOR 14 DAYS. THE DIALYSATE TESTS WERE STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432273 COIL CATH C CA2 DIALYSIS CATHETER MSD COVIDIEN MANUFACTURING SOLUTIONS SA 8888411702 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR