BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1842075 · Received August 27, 2010

    Report

    Report Number
    1036844-2010-00260
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJS
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WAS FOUND LEAKING AT THE WHITE CROSS SHAPED PIECE AND AS A RESULT, THE PATIENT WAS REFERRED TO PICC SERVICE FOR REINSERTION OF A NEW LINE. THE INSERTION SITE WAS THE BRACHIAL VEIN IN THE LEFT UPPER ARM. THE DATE OF INSERTION IS UNK; HOWEVER, IT WAS REPORTEDLY IN PLACE FOR SOME TIME, BUT DID NOT LEAK UNTIL THIS POINT. THERE WERE NO PATIENT COMPLICATIONS FROM THE TWO DAY DELAY, HOWEVER, THERE WAS A CONCERN FOR AN INCREASED RISK OF INFECTION AND/OR OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR