BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1934642 · Received November 24, 2010

    Report

    Report Number
    1036844-2010-00360
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    MSD
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMALE PT HAD A CANNON CATHETER IN PLACE AND IT WAS DISCOVERED THAT THE BLUE HUB WAS CRACKED. ADDITIONAL INFORMATION RECEIVED ON 11/17/2010 FROM THE SALES REPRESENTATIVE STATED, THE CATHETER BEING USED WAS AN EDGE CHRONIC CATHETER, NOT A CANNON CATHETER. DUE TO THE BLUE HUB CRACKING A CATHETER EXCHANGE WAS PERFORMED. THE PT HAD TO STOP DIALYSIS FOR A DAY OR SO (COUPLE OF HOURS). THERE WAS NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK