BEUDAMED
    FDA Adverse Event Summary report: N

    BEELINE ADMINISTRATION SET

    MDR report key: 3704524 · Received March 14, 2014

    Report

    Report Number
    1722139-2014-00060
    Date Received
    March 14, 2014
    Date of Event
    December 25, 2013
    Report Date
    February 13, 2014
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K042228
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STATEMENT RECEIVED FROM PATIENT'S DAD STATES THAT THERE WERE NO INSTRUCTIONS OR DIRECTION EXPLAINING ON HOW TO REMOVE THE TUBE. THEY WERE TOLD THAT IT WAS EASILY TO REMOVE AND JUST TO PULL IT OUT. PRODUCT WAS NOT RETURNED FOR EVALUATION, COMPLAINT CANNOT BE VERIFIED. LOT NUMBER CP19668 PROVIDED WAS MOST LIKELY FROM FORMALLY A MOOG MEDICAL DEVICES GROUP COMPANY. ATTEMPTS TO CONTACT THEM AND PROVIDE A DHR REVIEW HAVE FAILED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN ARTHROSCOPIC LABRAL REPAIR AT THE HOSPITAL, THE 275 ML 5" 5ML/HR BEELINE WAS IMPLANTED AT THE END OF THE PROCEDURE. FORTY EIGHT HOURS POST PROCEDURE, THE PATIENT WAS AT HOME REMOVING THE CATHETER. THE PLASTIC BROKE AND EXPOSED IN INTERNAL WIRE AND LEFT THE DISTAL 5 CM OF THE CATHETER IN THE WOUND. THE PATIENT WAS INVOLVED AS THEY WERE THE ONE REMOVING THE CATHETER AS PER THE GUIDELINES PROVIDED. THE PATIENT RETURNED TO HOSPITAL ON THE NEXT DAY ((B)(6) 2013) TO HAVE THE REMAINDER OF THE CATHETER REMOVAL UNDER GENERAL ANAESTHETIC IN AN ARTHROSCOPIC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154459 BEELINE ADMINISTRATION SET FRN MOOG MEDICAL DEVICES GROUP BL2D005YK6-CP CP19668

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention NAROPIN