BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 7 FR X 30 CM

    MDR report key: 3851598 · Received April 18, 2014

    Report

    Report Number
    1036844-2014-00181
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 13, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN REMOVING THE SWG, THE SWG UNRAVELED. THIS COMPLAINT WAS ORIGINALLY REPORTED AS A CATHETER LEAK, (SEE MDR 1036844-2014-00132), HOWEVER WHEN THE SAMPLE RETURNED, THE SWG WAS FOUND UNRAVELED AS WELL. AS A RESULT, A NEW KIT WAS OPENED AND SUCCESSFULLY USED TO RESOLVE BOTH THE DILATOR AND SWG ISSUES. A DELAY WAS REPORTED, HOWEVER, THERE WERE NO ADDITIONAL COMPLICATIONS AS A RESULT OF THESE OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238410 CVC SET: 3-LUMEN 7 FR X 30 CM ARROWG+ARD CATHETER PRODUCT FOZ ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1