BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMALLBORE EXTENSION ULTRASITE INJECTION SITE

    MDR report key: 877210 · Received July 9, 2007

    Report

    Report Number
    2647836-2007-00009
    Event Type
    Other
    Date Received
    July 9, 2007
    Date of Event
    June 9, 2007
    Report Date
    July 6, 2007
    Manufacturer
    B. BRAUN MEDICAL INC
    Product Code
    FPA
    PMA / PMN Number
    K760385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS DISCARDED AND WAS NOT MADE AVAILABLE FOR THE MANUFACTURER TO EVALUATE. WITHOUT THE ACTUAL SAMPLE, A THROUGH EVALUATION COULD NOT BE PERFORMED. THERE HAS BEEN NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED PART. NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: DURING CHEMO INFUSION OF 5FU, PT DISCOVERED LEAKING. IV D/C, LINE FLUSHED BY NURSE. LEAKING FROM ULTRASITE VALVE NOTED BELOW THREADS. VALVE SWABBED W/ ALCOHOL PRIOR TO INFUSION. FACILITY DISPOSED OF VALVE. ADDITIONAL INFORMATION PROVIDED BY THE USER FACILITY INDICATED THE VALVE LEAKED FROM A CRACK ALONG THE SIDE OF THE VALVE BELOW THE THREADS. NO ONE SUFFERED ANY ADVERSE SEQUELA ASSOCIATED WITH THE INCIDENT. THE LOT NUMBER REMAINS UNKNOWN AND THE ACTUAL SAMPLE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALLBORE EXTENSION ULTRASITE INJECTION SITE SMALLBORE EXTENSION SET FPA B. BRAUN MEDICAL INC CSE12LB UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR