BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 2031611 · Received March 23, 2011

    Report

    Report Number
    1226348-2011-00116
    Event Type
    Injury
    Date Received
    March 23, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC. MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K954021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE NURSE NOTICED THAT THE TUBING HAD SNAPPED OFF FROM THE NEEDLE FREE PORT. LEAKAGE WAS NOT REPORTED, HOWEVER, IT MIGHT BE POSSIBLE THAT LEAKAGE MAY HAVE OCCURRED GIVEN THE LOCATION OF THE BREAK. THE SYSTEM WAS REMOVED AND A NEW ONE CONNECTED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention