BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-MED CENTRAL VENOUS CATHETER SET WITH AMC THROMBOSHIELD

    MDR report key: 2162753 · Received July 14, 2011

    Report

    Report Number
    2015691-2011-15862
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    February 2, 2011
    Report Date
    June 16, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    FOZ
    PMA / PMN Number
    K955839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS WERE MADE TO CLARIFY THE REPORT OF "DISCONNECTION" AND "BLEEDING". THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT RETURN OF THE PRODUCT, NOR COULD A ROOT CAUSE OR POTENTIAL CONTRIBUTING FACTORS BE IDENTIFIED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE FORTHCOMING. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET SPECIFICATION UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER BECAME DISCONNECTED FROM THE EQUIPMENT DURING USE AND THE PATIENT EXPERIENCED BLEEDING. THE AMOUNT OF "BLEEDING" WAS NOT SPECIFIED. THE PATIENT ALSO PRESENTED AN INFECTION BUT THE CUSTOMER STATED THE INFECTION WAS NOT RELATED TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-MED CENTRAL VENOUS CATHETER SET WITH AMC THROMBOSHIELD MUTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER FOZ EDWARDS LIFESCIENCES, PR M3720HE 58949113

    Patients

    Seq Age Sex Outcome Treatment
    1