BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORFLO CORLOCK CORPORT (PEG KIT 12 FR)

    MDR report key: 1070755 · Received July 1, 2008

    Report

    Report Number
    1419949-2008-00002
    Event Type
    Other
    Date Received
    July 1, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 30, 2008
    Manufacturer
    VIASYS MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K882867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT CONFIGURATION IS ONLY SOLD TO THE (B) (6). A SMALL LEAK WAS FOUND BETWEEN THE MALE LUER AND THE Y PORT. THIS IS NOT A NEW COMPONENT OR CONFIGURATION. THE BOND BETWEEN THE MALE LUER AND THE Y PORT ON THE RETURNED SAMPLE HAD FAILED. EVIDENCE OF BONDING SOLUTION WAS APPARENT. THE BOND BETWEEN THE MALE LUER AND Y PORT CAN FAIL OVER TIME AS ADDITIONAL COMPONENTS ARE ATTACHED TO THE MALE LUER AND THE MALE LUER IS THEN TURNED THUS PUTTING STRESS ON THE BOND AREA. SEVERAL RETENTION SAMPLES OF THIS COMPONENT WERE EVALUATED AND THE MALE LUER WAS FOUND TO BE SECURELY BONDED TO THE Y PORT.

    Description of Event or Problem · 1

    NEW PURPLE Y-ADAPTER DIFFERENT TO PREVIOUS ONE, AND NEW REMOVABLE PORT CAUSING LEAKAGE OF FEED INTO BED WHILST PT ON INSULIN. LEAKAGE OF FEED INTO BED - "NEAR MISS" RECORDED. HAD NURSE NOT SPOTTED, THIS WOULD CAUSE INSULIN TO WORK AGAINST LESS FEED AND RISK OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORFLO CORLOCK CORPORT (PEG KIT 12 FR) PEG KNT VIASYS MEDSYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening