BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTIMICROBIAL PICC KIT 1-LUMEN: 4.5 FR X

    MDR report key: 2243890 · Received August 24, 2011

    Report

    Report Number
    1036844-2011-00279
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 18, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJS
    PMA / PMN Number
    K100635
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS CUSTOMER HAS BEEN TRIALING THE ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (AM PICC) SINCE THE BEGINNING OF MAY. THE LEAD INTERVENTIONAL RADIOLOGY (IR) TECH COMPLAINED ORIGINALLY TO THE INFECTION CONTROL PRACTITIONERS THAT THE CATHETER WAS CRACKING AND LEAKING. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED WITH A BARD CATHETER. THEY DO NOT KNOW IF THIS CAUSED A DELAY IN TREATMENT. THERE WAS NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. THE LEAD IR TECH COULD NOT PIN POINT EXACTLY WHAT THE ISSUE WAS AND WHERE EXACTLY THE CATHETER WAS LEAKING. THIS CUSTOMER IS A BARD ACCOUNT AND THE LEAD IR TECH STATED "THIS ISN'T THE BARD CATHETER AND THERE IS NO SIGNIFICANT BENEFIT TO USING THIS CATHETER OVER OUR BARD CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTIMICROBIAL PICC KIT 1-LUMEN: 4.5 FR X PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BARD CATHETER