BEUDAMED
    FDA Adverse Event Other Summary report: N

    NA

    MDR report key: 747418 · Received August 10, 2006

    Report

    Report Number
    2647836-2006-00009
    Event Type
    Other
    Date Received
    August 10, 2006
    Date of Event
    July 12, 2006
    Report Date
    August 4, 2006
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FOZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS NOT RETURN FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. HOWEVER, TWENTY FIVE UNUSED SAMPLES FROM THE REPORTED LOT WERE PHYSICALLY TESTED AND 4/25 SAMPLES LEAKED DUE TO A HOLE IN THE LUER TAPER OF THE CATHETER PLUG. THESE PARTS ARE MANUFACTURED AND PURCHASED FROM SMITHS MEDICAL/MEDEX INC. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO SMITHS MEDICAL/MEDEX INC. FOR EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED BY THE END USER FACILITY: LEAKING AT THE THREADS. THIS HAS OCCURRED IN AN MRI CLINIC AND CAUSED NUCLEAR MED SPILL. ADDITIONAL INFORMATON RECEIVED FROM THE END USER FACILITY INDICATED THERE WAS NO PT INJURY OR EXPOSURE TO INJURY RELATED TO THIS INCIDENT. THE ACTUAL SAMPLE HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA EXTENDED IV CATHETER FOZ B. BRAUN MEDICAL INC. NA 60812452

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other