BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CATH SET: 20 GA X 8

    MDR report key: 1915508 · Received November 5, 2010

    Report

    Report Number
    1036844-2010-00335
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REFERENCE MDR #1036844-2010-00334 FOR THE FIRST EVENT AND MDR #1036844-2010-00336 FOR THE THIRD EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT A SECOND KIT WAS OPENED AND DURING INSERTION INTO THE PT'S FEMORAL VEIN, THEY EXPERIENCED DIFFICULTY WITH THE SPRING WIRE GUIDE (SWG). AS A RESULT, IT WAS REMOVED INTACT AND THEY NOTICED IT WAS FRAYED. THERE WERE NO REPORTED PT COMPLICATIONS, PT INJURY OR DEATH. THE DELAY IN THERAPY IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL CATH SET: 20 GA X 8 ARTERIAL CATHETER PRODUCTS DQX ARROW INTL., INC. RF8016340

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK