BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELSITE

    MDR report key: 339829 · Received June 27, 2001

    Report

    Report Number
    2523676-2001-00021
    Event Type
    Other
    Date Received
    June 27, 2001
    Date of Event
    May 31, 2001
    Report Date
    June 20, 2001
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PORT FLIPPED OVER IN PATIENT ON TWO SEPARATE OCCASIONS, APPROXIMATELY 3 WEEKS APART. THE PHYSICIAN WHO PERFORMED THE PORT PLACEMENT DID NOT SUTURE PORT IN PLACE. CONSULTATION WITH THE IMPLANTING PHYSICIAN CONFIRMED THAT THE PORTS WERE NOT SUTURED IN PLACE. THE IFU FOR THE PRODUCT STATES: "AFTER CONFIRMING CATHETER PATENCY, SECURE THE PORT IN PLACE TO THE UNDERLYING FASCIA WITH 2-0 OR 3-0 MONOFILAMENT NON-ABSORBABLE SUTURE (E.G. POLYPROPYLENE) USING THE HOLES PROVIDED IN THE PORT BASEPLATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29160 CELSITE IMPLANTABLE PORT LJT B. BRAUN MEDICAL, INC. ST401L UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN