BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 7 FR X 16 CM

    MDR report key: 1883095 · Received October 15, 2010

    Report

    Report Number
    9680794-2010-00070
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 INTRODUCER NEEDLE HAD A CRACKED HUB. THERE WERE NO PATIENT COMPLICATIONS OR DELAY IN THERAPY REPORTED. NO INTERVENTION REQUIRED. ADDITIONAL INFORMATION RECEIVED ON 10/12/2010, FROM THE SALES REPRESENTATIVE CONFIRMED THAT WHEN THE 18 GA INTRODUCER NEEDLE WAS PLACED IN THE PATIENT, THE PHYSICIAN DISCOVERED THE NEEDLE HUB WAS CRACKED. AS A RESULT, THE NEEDLE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. IT IS NOTED THAT THE INSERTION SITE IS "UNKNOWN." THE OUTCOME OF THE PATIENT IS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 7 FR X 16 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC CF0043137

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN