BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESEP-CENTRAL VENOUS OXIMETRY CATHETER KIT

    MDR report key: 1163070 · Received September 15, 2008

    Report

    Report Number
    6000002-2008-08639
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K053609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED; DISPOSED AT HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERNAL JUGULAR VEIN WAS INJURED DURING THE DILATOR INSERTION. ASTRICTION WAS PERFORMED BY HAND FOR A DAY. NO COMPLICATIONS REPORTED AT THIS MOMENT. FOLLOW UP WITH CUSTOMER, INDICATED THAT THERE WAS NO PT COMPLICATIONS REPORTED. THE DILATOR AND GUIDE WIRE WERE REMOVED AND ANOTHER CENTRAL VENOUS CATHETER (ARROW PRODUCT) WAS INSERTED. ASTRICTION WAS USED TO STOP BLEEDING BY APPLYING PRESSURE TO THE WOUND. FURTHER FOLLOW UP WITH CUSTOMER, INDICATED, THAT IT WAS UNK ON HOW MUCH BLOOD WAS LOST AND THE WOUND WAS AT THE INTERNAL JUGULAR VEIN. NO PRODUCT WILL BE RETURNED, DEVICE DISCARDED AT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESEP-CENTRAL VENOUS OXIMETRY CATHETER KIT CENTRAL VENOUS CATHETER DQE EDWARDS LIFESCIENCES, PR X3820HSJD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other