BEUDAMED
    FDA Adverse Event Other Summary report: N

    6000096-1999-00083

    MDR report key: 257450 · Received December 30, 1999

    Report

    Report Number
    6000096-1999-00083
    Event Type
    Other
    Date Received
    December 30, 1999
    Date of Event
    December 9, 1999
    Report Date
    December 10, 1999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LEAKAGE FROM CLAVE VALVE REPORTED. A NURSE WAS ADMINISTERED AN UNSPECIFIC AMOUNT OF MORPHINE AS A BOLUS INTO THE IV TUBING VIA CLAVE PORT WITH A LUER LOCK SYRINGE. THE CUSTOMER STATED THAT THE NURSE USED THE SYRINGE NEEDLE TO ACCESS THE PORT, AND WHEN IT WAS REMOVED, NOTICED FLUID COMING OUT OF THE CLAVE PORT AND BLOOD BACKING UP THE LINE. REPORTEDLY THE NURSE PLACED A "PRE-PIERCED DEAD ENDER AT THE END OF THE CLAVE PORT TO STOP THE LEAKING." THE LEAKING WAS NOTICED RIGHT AWAY BY THE NURSE AND SO CUSTOMER BELIEVES THAT NO BLOOD LOSS OCCURRED. NO PT HARM WAS REPORTED. THE CUSTOMER ALSO STATED THAT THE INCIDENT OCCURRED BECAUSE OF USER ERROR BY ACCESS OF THE CLAVE PORT WITH A NEEDLE. ADD'L PT INFO WAS REQUESTED, BUT NO INFO HAS BECOME AVAILABLE.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other