BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BETA CAP ADAPTER

    MDR report key: 2961968 · Received January 22, 2013

    Report

    Report Number
    1317749-2013-00042
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 21, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A BETA CAP ADAPTER. THE CUSTOMER STATES THAT OVER TIME, THE BETA CAP ADAPTER IS CAUSING A HOLE IN THE PD CATHETER. THERE IS A SHARP EDGE ON THE BOTTOM OF THE BETA CAP ADAPTER. THE CATHETER WAS PLACED ON (B)(6) 2010 AND REPAIRED ON (B)(6) 2013. THE CATHETER WAS CUT DOWN AND THE ADAPTER WAS REPAIRED. THE PATIENT WAS ALSO ADMINISTERED PROPHYLACTIC ANTIBIOTICS AS A PRECAUTION TO PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31616 BETA CAP ADAPTER BETA CAP ADAPTER FJS COVIDIEN 8814661001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN