BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOT APPLICABLE

    MDR report key: 752781 · Received July 28, 2006

    Report

    Report Number
    2647836-2006-00010
    Event Type
    Other
    Date Received
    July 28, 2006
    Report Date
    July 24, 2006
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FOZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS NOT RETURNED FOR EVALUATION. ELEVEN UNUSED SAMPLES FROM THE REPORTED LOT WERE RETURNED. THE SAMPLES WERE PHYSICALLY TESTED AND FOUND TO BE ACCEPTABLE. AN ADDITIONAL 100 SAMPLES WERE ALSO RETURNED FORM THE REPORTED LOT. TWENTY FIVE SAMPLES WERE PHYSICALLY TESTED AND 4/25 WERE NOTED TO LEAK DUE TO A HOLE IN THE LUER TAPER OF THE CATHETER PLUG. THESE PARTS ARE MANUFACTURED AND PURCHASED FROM SMITHS MEDICAL/MEDEX INC. THE SAMPLES AND ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO SMITHS MEDICAL/MEDEX INC. FOR EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: LEAKAGE OF BLOOD AND FLUID AT THE THREADED CONNECTIONS TO THE IV CATHETERS. ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY INDICATED NO PATIENT INJURY OR EXPOSURE TO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOT APPLICABLE EXTENDED IV CATHETER FOZ B. BRAUN MEDICAL INC. NA 60812452

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other