BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORLFO

    MDR report key: 1130803 · Received August 14, 2008

    Report

    Report Number
    1419949-2008-00003
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 12, 2008
    Manufacturer
    VIASYS MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K840656
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETENTION SAMPLES WERE TESTED BY PLACING FEEDING SETS INTO G TUBES. ABOUT HALF OF THE UNITS THAT WERE DIPPED QUICKLY IN ALCOHOL HAD CRACKED AFTER BEING MATED TO A G-TUBE SEVERAL TIMES. UNITS THAT WERE NOT DIPPED IN ALCOHOL REMAINED FAIRLY EASY TO REMOVE AND RE-INSERT INTO THE G-TUBES AND NO SIGNS OF CRACKING WERE SEEN. WITHOUT A SAMPLE INVOLVED WITH THIS PARTICULAR REPORT, WE ARE UNABLE TO DETERMINE THE EXACT CAUSE FOR THE REPORTED CRACKING.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: PLASTIC TIP OF FEEDING TUBE EXTENSION SET BROKE OFF AND BECAME LODGED IN BABY'S GASTROSTOMY TUBE. SURGEON HAD TO BRING SPECIAL INSTRUMENTATION TO NICU FROM OR TO EXTRACT THE BROKEN PIECE. NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORLFO ENTERAL Y EXTENSION SET KNT VIASYS MEDSYSTEMS NA 32806

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO