BEUDAMED
    FDA Adverse Event Other Summary report: N

    PVC UVC

    MDR report key: 291135 · Received August 16, 2000

    Report

    Report Number
    1314426-2000-00004
    Event Type
    Other
    Date Received
    August 16, 2000
    Date of Event
    June 20, 2000
    Report Date
    August 11, 2000
    Manufacturer
    THE KENDALL COMPANY
    Product Code
    FOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 6/20/00 CONTACT WAS MADE WITH THE EQUIPMENT SUPPLY COORDINATOR WHO THEN REFERRED THE MFR TO THE CLINICAL RESOURCE NURSE. THE CLINICAL RESOURCE NURSE STATED THAT THE CATHETER IN QUESTION HAD BEEN INSERTED INTO A NEW ADMISSION WITHOUT INCIDENT. THERE WAS BLEEDING NOTED AT THAT TIME. AN X-RAY WAS PERFORMED TO VERIFY PLACEMENT 30 MINUTES AFTER INSERTION. THERE WAS NO BLEEDING NOTED ON THE X-RAY, BUT IT WAS FOUND THAT THE CATHETER NEEDED TO BE PULLED BACK FOR OPTIMAL PLACEMENT. IN ORDER TO REPOSITION THE CATHETER, A STERI-STRIP THAT HAD BEEN APPLIED TO THE CATHETER TO PREVENT MOVEMENT HAD TO BE REMOVED FROM THE CATHETER. A STAFF MEMBER REMOVED THE STERI-STRIP FROM THE CATHETER CAUSING THE CATHETER LUMEN TO SPLIT WHICH IN TURN CAUSED BACKFLOW OF BLOOD THROUGH THE CATHETER. THE CATHETER WAS IMMEDIATELY CLAMPED. THE INFANT INVOLVED DID NOT SUFFER ANY ADVERSE EFFECTS AND WAS FOUND TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PVC UVC UVC 3.5 FR FOS THE KENDALL COMPANY * 400969

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention