BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTIPLEX CONTINUOUS PLEXUSTRAY W/ ACCUFUSER

    MDR report key: 1032469 · Received April 16, 2008

    Report

    Report Number
    2523676-2008-00021
    Event Type
    Other
    Date Received
    April 16, 2008
    Date of Event
    March 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K030830
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS NOT RETURNED TO THE MANUFACTURER TO BE EVALUATED. HOWEVER, TWO PHOTOGRAPHS OF THE KNOTTED CATHETER WERE RETURNED, ALONG WITH AN UNUSED REPRESENTATIVE CATHETER SAMPLE. THERE WERE NO VISUAL MANUFACTURING DEFECTS NOTED ON THE RETURNED UNUSED CATHETER. THE PHOTO DEPICTED THE CATHETER LOOPED AND KNOTTED IN SEVERAL PLACES. INCIDENTS OF THIS NATURE CAN GENERALLY BE ATTRIBUTED TO EXCESSIVE CATHETER THREADING WHICH INCREASES THE LIKELIHOOD OF ENTANGLEMENT. BASED ON THE PHOTOGRAPH ANALYSIS AND THE ADDITIONAL INFORMATION PROVIDED BY THE FACILITY, IT APPEARS THAT THE CATHETER MAY HAVE BEEN THREADED TOO FAR INTO THE AXILLARY AREA. HOWEVER, WITHOUT THE ACTUAL SAMPLE, NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE UNUSED SAMPLE AND THE PHOTOGRAPHS ALONG WITH ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE MANUFACTURER B. BRAUN FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: FEMALE PATIENT. PROCEDURE PERFORMED. EXPERIENCED NO DIFFICULTY PLACING CATHETER. REQUIRED SURGICAL REMOVAL BY OPENING UP THE AXILLARY AREA. CATHETER WAS FOUND TO BE KNOTTED. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THE SURGERY TO REMOVE THE CATHETER WAS PERFORMED WITHOUT INCIDENT AND THE PATIENT HAS NOT SUFFERED ANY ADDITIONAL ADVERSE SEQUELA ASSOCIATED WITH THIS INCIDENT. IT WAS ALSO REPORTED THE PHYSICIAN ADVANCED THE CATHETER 6CM, DURING THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTIPLEX CONTINUOUS PLEXUSTRAY W/ ACCUFUSER CONTIPLEX CONTINUOUS NERVE BLOCK KIT CAZ B. BRAUN MEDICAL, INC. NA 60858609

    Patients

    Seq Age Sex Outcome Treatment
    1 Other